FDA records in 2023
OQRO holds 477 FDA records in 2023 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 32 listed companies. Stryker Corporation (SYK) has the most, with 105, ahead of Becton Dickinson (49) and Cardinal Health (49). By kind: 380 recalls, 69 device clearances (510(k)), 24 drug approvals, 4 device approvals (PMA). The busiest month was December, with 184.
- FDA records
- 477
- Companies
- 32
- with at least one on file
- Most frequent: kind of action
- Recall
- 380
- Most on file
- SYK
- Stryker Corporation, 105
FDA records per month, 2023
Companies with the most FDA records, 2023
By kind of action, 2023
- Recall380
- Device clearance (510(k))69
- Drug approval24
- Device approval (PMA)4
The most recent FDA records of 2023
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends th…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends th…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health b…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends th…
Cardinal Health CAHAction date Dec 28, 2023
Recall, Class I: Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends th…
Johnson & Johnson JNJAction date Dec 27, 2023
Recall, Class I: Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
Filed as Abiomed, Inc. · IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Johnson & Johnson JNJAction date Dec 27, 2023
Recall, Class II: Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
Filed as Abiomed, Inc. · New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
Stryker Corporation SYKAction date Dec 26, 2023
Device clearance (510(k)): POWEReam 1/4 Drive
510(k) clearance, traditional: Substantially Equivalent
Viatris VTRSAction date Dec 26, 2023
Drug approval: Posaconazole
Filed as MYLAN LABS LTD · Generic drug approved. Active ingredient: Posaconazole
GE HealthCare GEHCAction date Dec 26, 2023
Recall, Class II: Senographe Pristina
Filed as GE Medical Systems, SCS · X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Cencora CORAction date Dec 26, 2023
Recall, Class III: Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Col…
Filed as Amerisource Health Services LLC · Superpotent drug: Assay results were slightly above specification at the time zero point.
Analog Devices ADIAction date Dec 22, 2023
Device clearance (510(k)): CPM System
510(k) clearance, traditional: Substantially Equivalent
Baxter International BAXAction date Dec 22, 2023
Recall, Class I: Baxter Exactamix Pro 2400, REF EXM24DY
Filed as Baxter Healthcare Corporation · An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the re…
Baxter International BAXAction date Dec 22, 2023
Recall, Class I: Baxter Exactamix Pro 1200, REF EXM12DY
Filed as Baxter Healthcare Corporation · An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the re…
GE HealthCare GEHCAction date Dec 22, 2023
Recall, Class II: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized ar…
Stryker Corporation SYKAction date Dec 22, 2023
Recall, Class II: HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Filed as Howmedica Osteonics Corp. · Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Stryker Corporation SYKAction date Dec 22, 2023
Recall, Class II: HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Filed as Howmedica Osteonics Corp. · Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Stryker Corporation SYKAction date Dec 21, 2023
Device clearance (510(k)): Stryker Orthopaedics Hip Systems Labeling Update
Filed as Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510(k) clearance, traditional: Substantially Equivalent
Stryker Corporation SYKAction date Dec 21, 2023
Device clearance (510(k)): Hoffmann LRF System
510(k) clearance, special: Substantially Equivalent
Medtronic MDTAction date Dec 21, 2023
Recall, Class II: Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT…
Filed as Covidien LP · Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence…
Pfizer PFEAction date Dec 21, 2023
Recall, Class I: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Sy…
Presence of Particulate Matter; identified as glass
Pfizer PFEAction date Dec 21, 2023
Recall, Class I: Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL…
Presence of particulate matter: glass
Cardinal Health CAHAction date Dec 21, 2023
Recall, Class II: CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canist…
Cardinal Health CAHAction date Dec 21, 2023
Recall, Class II: Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canist…
Medtronic MDTAction date Dec 21, 2023
Recall, Class II: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 B…
Filed as Covidien LP · Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence…
Pfizer PFEAction date Dec 21, 2023
Recall, Class I: 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per…
Presence of Particulate Matter; identified as glass
Cardinal Health CAHAction date Dec 21, 2023
Recall, Class II: Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canist…
Pfizer PFEAction date Dec 21, 2023
Recall, Class I: Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton,…
Presence of Particulate Matter; identified as glass
Becton Dickinson BDXAction date Dec 20, 2023
Device clearance (510(k)): BD Vacutainer® Serum Separator (SST) Blood Collection Tubes
510(k) clearance, traditional: Substantially Equivalent
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Cooper Companies (The) COOAction date Dec 20, 2023
Recall, Class II: global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryo…
Filed as CooperSurgical, Inc. · The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Becton Dickinson BDXAction date Dec 20, 2023
Recall, Class II: Bard¿ Suction Connector with ENFit, REF EN0066000
Filed as C.R. Bard Inc · BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Johnson & Johnson JNJAction date Dec 19, 2023
Device clearance (510(k)): CORAIL Cemented Femoral Stem
Filed as Depuy Ireland UC · 510(k) clearance, traditional: Substantially Equivalent
Abbott Laboratories ABTAction date Dec 19, 2023
Device clearance (510(k)): JETiHydrodynamic Thrombectomy System
Filed as ABBOTT MEDICAL · 510(k) clearance, traditional: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 19, 2023
Drug approval: Erleada
Filed as JANSSEN BIOTECH · New use approved (efficacy supplement). Active ingredient: Apalutamide
Danaher Corporation DHRAction date Dec 19, 2023
Recall, Class II: REV 2 Flowcell Capsule Spare, Part Number: C04154
Filed as Beckman Coulter, Inc. · Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Danaher Corporation DHRAction date Dec 19, 2023
Recall, Class II: iQ Waste Well Adapter, Part Number: 700-3393
Filed as Beckman Coulter, Inc. · Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Danaher Corporation DHRAction date Dec 19, 2023
Recall, Class II: iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3…
Filed as Beckman Coulter, Inc. · Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Danaher Corporation DHRAction date Dec 19, 2023
Recall, Class II: Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Filed as Beckman Coulter, Inc. · Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Medtronic MDTAction date Dec 19, 2023
Recall, Class II: Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability fo…
Boston Scientific BSXAction date Dec 19, 2023
Recall, Class II: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may c…
Danaher Corporation DHRAction date Dec 18, 2023
Device clearance (510(k)): Access hsTnI
Filed as Beckman Coulter, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 18, 2023
Device clearance (510(k)): Ion Endoluminal System (IF1000)
510(k) clearance, traditional: Substantially Equivalent
Abbott Laboratories ABTAction date Dec 18, 2023
Recall, Class II: TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Filed as St. Jude Medical, Atrial Fibrillation Division, Inc. · When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some…
Steris STEAction date Dec 15, 2023
Device clearance (510(k)): ConFirm 20 Minute Incubator
510(k) clearance, special: Substantially Equivalent
Steris STEAction date Dec 15, 2023
Device clearance (510(k)): VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
510(k) clearance, special: Substantially Equivalent
Align Technology ALGNAction date Dec 15, 2023
Device clearance (510(k)): Invisalign Palatal Expander System
510(k) clearance, traditional: Substantially Equivalent
Merck MRKAction date Dec 15, 2023
Drug approval: Keytruda
New use approved (efficacy supplement). Active ingredient: Pembrolizumab
Merck MRKAction date Dec 15, 2023
Drug approval: Keytruda
New use approved (efficacy supplement). Active ingredient: Pembrolizumab
Johnson & Johnson JNJAction date Dec 14, 2023
Device clearance (510(k)): VELYS Robotic-Assisted Solution
Filed as Depuy Ireland UC · 510(k) clearance, special: Substantially Equivalent
Merck MRKAction date Dec 14, 2023
Drug approval: Welireg
New use approved (efficacy supplement). Active ingredient: Belzutifan
Pfizer PFEAction date Dec 14, 2023
Drug approval: Cibinqo
New use approved (efficacy supplement). Active ingredient: Abrocitinib
Medtronic MDTAction date Dec 13, 2023
Device approval (PMA): PulseSelect Pulsed Field Ablation (PFA) system
Premarket approval (PMA): Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
GE HealthCare GEHCAction date Dec 13, 2023
Device clearance (510(k)): CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Filed as Ge Medical Systems Information Technologies, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Boston Scientific BSXAction date Dec 12, 2023
Device clearance (510(k)): StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
510(k) clearance, special: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 12, 2023
Device clearance (510(k)): TriALTIS Spine System
Filed as Medos International SARL · 510(k) clearance, special: Substantially Equivalent
Steris STEAction date Dec 12, 2023
Recall, Class II: Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
Steris STEAction date Dec 12, 2023
Recall, Class II: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
Johnson & Johnson JNJAction date Dec 12, 2023
Recall, Class II: TECNIS Toric II OptiBlue IOL Models ZCW
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Johnson & Johnson JNJAction date Dec 11, 2023
Device clearance (510(k)): ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
Filed as Depuy Ireland UC · 510(k) clearance, traditional: Substantially Equivalent
Boston Scientific BSXAction date Dec 11, 2023
Device clearance (510(k)): FARADRIVE Steerable Sheath
510(k) clearance, traditional: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 11, 2023
Recall, Class II: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping…
Filed as Ethicon Endo-Surgery Inc · There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may re…
Stryker Corporation SYKAction date Dec 8, 2023
Device clearance (510(k)): Global Modular Replacement System
Filed as Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 510(k) clearance, traditional: Substantially Equivalent
Becton Dickinson BDXAction date Dec 8, 2023
Device clearance (510(k)): PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG E…
Filed as Bard Peripheral Vascular, Inc. · 510(k) clearance, special: Substantially Equivalent
Steris STEAction date Dec 8, 2023
Device clearance (510(k)): VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
510(k) clearance, special: Substantially Equivalent
Baxter International BAXAction date Dec 8, 2023
Recall, Class II: XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-03…
Filed as Baxter Healthcare Corporation · Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Baxter International BAXAction date Dec 8, 2023
Recall, Class II: Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM…
Filed as Baxter Healthcare Corporation · Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Baxter International BAXAction date Dec 8, 2023
Recall, Class II: XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6…
Filed as Baxter Healthcare Corporation · Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Medtronic MDTAction date Dec 7, 2023
Device clearance (510(k)): DLP Silicone Coronary Artery Ostial Cannulae
510(k) clearance, special: Substantially Equivalent
GE HealthCare GEHCAction date Dec 7, 2023
Device clearance (510(k)): LOGIQ Totus
Filed as GE Medical Systems Ultrasound and Primary Care Diagnostics · 510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Dec 7, 2023
Recall, Class II: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the te…
Medtronic MDTAction date Dec 6, 2023
Device clearance (510(k)): LINQ II Insertable Cardiac Monitor
510(k) clearance, special: Substantially Equivalent
Baxter International BAXAction date Dec 6, 2023
Recall, Class II: Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
Filed as Baxter Healthcare Corporation · Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Pres…
Baxter International BAXAction date Dec 6, 2023
Recall, Class II: Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product C…
Filed as Baxter Healthcare Corporation · Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Pres…
Baxter International BAXAction date Dec 6, 2023
Recall, Class II: Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM…
Filed as Baxter Healthcare Corporation · Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Pres…
Baxter International BAXAction date Dec 6, 2023
Recall, Class II: Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b)…
Filed as Baxter Healthcare Corporation · Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Pres…
Baxter International BAXAction date Dec 6, 2023
Recall, Class II: PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14…
Filed as Baxter Healthcare Corporation · Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Pres…
100 of 477 shown; every record is on its company’s page.
Common questions
How many FDA records were there in 2023?
OQRO holds 477 FDA records in 2023 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 32 listed companies.
Which company had the most FDA records in 2023?
Stryker Corporation (SYK) has the most, with 105, ahead of Becton Dickinson (49) and Cardinal Health (49).
Where does the data come from?
FDA (Drugs@FDA, 510(k), PMA, enforcement reports), read on a schedule and matched to listed companies by name. Each record is matched to a listed company by the sponsor, applicant or recalling firm name as filed. The action date is the approval or decision date; for a recall, the date the firm started it. Unmatched firms (private companies, foreign subsidiaries under another name) are not listed.
