FDA records in 2024
OQRO holds 1,354 FDA records in 2024 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 54 listed companies. Boston Scientific (BSX) has the most, with 167, ahead of Medtronic (125) and Becton Dickinson (123). By kind: 963 recalls, 268 device clearances (510(k)), 115 drug approvals, 8 device approvals (PMA). The busiest month was March, with 168.
- FDA records
- 1,354
- Companies
- 54
- with at least one on file
- Most frequent: kind of action
- Recall
- 963
- Most on file
- BSX
- Boston Scientific, 167
FDA records per month, 2024
Companies with the most FDA records, 2024
By kind of action, 2024
- Recall963
- Device clearance (510(k))268
- Drug approval115
- Device approval (PMA)8
The most recent FDA records of 2024
Abbott Laboratories ABTAction date Dec 31, 2024
Device clearance (510(k)): MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
Filed as ABBOTT MEDICAL · 510(k) clearance, traditional: Substantially Equivalent
Bristol Myers Squibb BMYAction date Dec 27, 2024
Drug approval: Opdivo Qvantig
Filed as BRISTOL-MYERS SQUIBB · Biologic approved. Active ingredient: Nivolumab, Hyaluronidase-Nvhy
Bristol Myers Squibb BMYAction date Dec 27, 2024
Drug approval: Opdivo Qvantig
Filed as BRISTOL-MYERS SQUIBB · Biologic approved. Active ingredient: Nivolumab, Hyaluronidase-Nvhy
Amgen AMGNAction date Dec 26, 2024
Drug approval: Wezlana
New use approved (efficacy supplement). Active ingredient: Ustekinumab-Auub
Johnson & Johnson JNJAction date Dec 23, 2024
Device clearance (510(k)): INHANCE INTACT
Filed as Depuy Ireland UC · 510(k) clearance, traditional: Substantially Equivalent
Viatris VTRSAction date Dec 23, 2024
Drug approval: Arixtra
Filed as MYLAN IRELAND LTD · New use approved (efficacy supplement). Active ingredient: Fondaparinux Sodium
Viatris VTRSAction date Dec 23, 2024
Recall, Class II: Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505…
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris VTRSAction date Dec 23, 2024
Recall, Class II: Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Zimmer Biomet ZBHAction date Dec 20, 2024
Device clearance (510(k)): Zimmer® Persona® Personalized Knee System
510(k) clearance, traditional: Substantially Equivalent
GE HealthCare GEHCAction date Dec 20, 2024
Device clearance (510(k)): Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Filed as GE Medical Systems Ultrasound and Primary Care Diagnostics · 510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Dec 20, 2024
Drug approval: Zepbound
New use approved (efficacy supplement). Active ingredient: Tirzepatide
Vertex Pharmaceuticals VRTXAction date Dec 20, 2024
Drug approval: Trikafta (Copackaged)
Filed as VERTEX PHARMS INC · New use approved (efficacy supplement). Active ingredient: Elexacaftor, Ivacaftor, Tezacaftor, Ivacaftor
Pfizer PFEAction date Dec 20, 2024
Drug approval: Braftovi
Filed as ARRAY BIOPHARMA INC · New use approved (efficacy supplement). Active ingredient: Encorafenib
Vertex Pharmaceuticals VRTXAction date Dec 20, 2024
Drug approval: Alyftrek
Filed as VERTEX PHARMS INC · New drug application approved. Active ingredient: Deutivacaftor, Tezacaftor, Vanzacaftor Calcium
Biogen BIIBAction date Dec 20, 2024
Drug approval: Skyclarys
New use approved (efficacy supplement). Active ingredient: Omaveloxolone
Vertex Pharmaceuticals VRTXAction date Dec 20, 2024
Drug approval: Trikafta (Copackaged)
Filed as VERTEX PHARMS INC · New use approved (efficacy supplement). Active ingredient: Elexacaftor, Ivacaftor, Tezacaftor, Ivacaftor
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class I: Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Filed as Baxter Healthcare Corporation · There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Johnson & Johnson JNJAction date Dec 20, 2024
Recall, Class II: PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation an…
Filed as Ethicon, LLC · Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and caus…
Baxter International BAXAction date Dec 20, 2024
Recall, Class II: Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Filed as Baxter Healthcare Corporation · Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Johnson & Johnson JNJAction date Dec 20, 2024
Recall, Class II: ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Filed as Ethicon, LLC · Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and caus…
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class I: Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Filed as Baxter Healthcare Corporation · There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class I: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Filed as Baxter Healthcare Corporation · There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class I: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Filed as Baxter Healthcare Corporation · There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class II: Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Filed as Baxter Healthcare Corporation · Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific BSXAction date Dec 20, 2024
Recall, Class II: AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Baxter International BAXAction date Dec 20, 2024
Recall, Class II: Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Filed as Baxter Healthcare Corporation · Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Johnson & Johnson JNJAction date Dec 20, 2024
Recall, Class II: PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
Filed as Ethicon, LLC · Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and caus…
Becton Dickinson BDXAction date Dec 19, 2024
Device clearance (510(k)): BD Vaginal Panel
510(k) clearance, special: Substantially Equivalent
Stryker Corporation SYKAction date Dec 19, 2024
Device clearance (510(k)): Broadway 8 Catheter
510(k) clearance, traditional: Substantially Equivalent
Stryker Corporation SYKAction date Dec 19, 2024
Device clearance (510(k)): Echo Intracranial Base Catheter
510(k) clearance, traditional: Substantially Equivalent
Thermo Fisher Scientific TMOAction date Dec 19, 2024
Device clearance (510(k)): The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,CADIERE FORCEPS,IS4000 REF 471049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a vari…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,FORCE BIPOLAR,IS4000 REF 470405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,COBRA GRASPER,IS4000 REF 471190
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, POTTS SCISSORS, IS4000 REF 470001
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Becton Dickinson BDXAction date Dec 19, 2024
Recall, Class II: BD PCR Cartridges used with MAX System. Model Number: 437519
Potential for signal drift in specific lots of BD PCR Cartridges.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,LONG TIP FORCEPS,IS4000 REF 471048
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedur…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical ISRGAction date Dec 19, 2024
Recall, Class II: 8MM,FORCE BIPOLAR,IS4000 REF 471405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Johnson & Johnson JNJAction date Dec 18, 2024
Drug approval: Invokamet XR
Filed as JANSSEN PHARMS · New use approved (efficacy supplement). Active ingredient: Canagliflozin, Metformin Hydrochloride
Johnson & Johnson JNJAction date Dec 18, 2024
Drug approval: Invokana
Filed as JANSSEN PHARMS · New use approved (efficacy supplement). Active ingredient: Canagliflozin
Johnson & Johnson JNJAction date Dec 18, 2024
Drug approval: Invokamet
Filed as JANSSEN PHARMS · New use approved (efficacy supplement). Active ingredient: Canagliflozin, Metformin Hydrochloride
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Comp…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, To…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, T…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography,…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
GE HealthCare GEHCAction date Dec 18, 2024
Recall, Class II: GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could…
100 of 1,354 shown; every record is on its company’s page.
Common questions
How many FDA records were there in 2024?
OQRO holds 1,354 FDA records in 2024 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 54 listed companies.
Which company had the most FDA records in 2024?
Boston Scientific (BSX) has the most, with 167, ahead of Medtronic (125) and Becton Dickinson (123).
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.
