Healthcare
FDA approvals, clearances and recalls by listed companies
Drug approvals, device clearances and approvals, and recalls recorded by the FDA for companies OQRO follows, newest first.
How to read it. An approval and a recall sit in the same collection and mean opposite things. Read the kind of record before the company name. Action date: the day the FDA approved, cleared, or classified the recall.
Guide: NDA, ANDA, 510(k), PMA: what each FDA route means
By year: 2023 · 2024 · 2025 · 2026
As of Oct 20, 2026, OQRO holds 3,887 FDA records from FDA (Drugs@FDA, 510(k), PMA, enforcement reports); the latest is dated Oct 9, 2026. The 100 shown below are the most recent. Over the last 12 months, Medtronic (MDT) has the most on file: 111.
FDA records per month, last 24 months · 2,310 in total
Most FDA records, last 12 months
100 of the 100 most recent shown (3,887 on file)
Eli Lilly LLYAction date Oct 9, 2026
Drug approval: Olumiant
New use approved (efficacy supplement). Active ingredient: Baricitinib
Amgen AMGNAction date Oct 9, 2026
Drug approval: Repatha
New use approved (efficacy supplement). Active ingredient: Evolocumab
Pfizer PFEAction date Oct 7, 2026
Drug approval: Tukysa
On the record as SEAGEN · New use approved (efficacy supplement). Active ingredient: Tucatinib
Novartis NVSAction date Oct 6, 2026
Drug approval: Rhapsido
New use approved (efficacy supplement). Active ingredient: Remibrutinib
Steris STEAction date Oct 2, 2026
Device clearance (510(k)): MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor
510(k) clearance, traditional: Substantially Equivalent
GE HealthCare GEHCAction date Oct 2, 2026
Device clearance (510(k)): Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
On the record as GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 510(k) clearance, traditional: Substantially Equivalent
GE HealthCare GEHCAction date Oct 2, 2026
Device clearance (510(k)): Lung Guidance
On the record as GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 510(k) clearance, traditional: Substantially Equivalent
Edwards Lifesciences EWAction date Oct 1, 2026
Device approval (PMA): Autus Size-Adjustable Valve
Premarket approval (PMA): Heart-valve, polymeric
Revvity RVTYAction date Sep 30, 2026
Device clearance (510(k)): Eonis SMA kit
510(k) clearance, traditional: Substantially Equivalent
Tela Bio TELAAction date Sep 28, 2026
Device clearance (510(k)): Liora Monofilament Scaffold
510(k) clearance, traditional: Substantially Equivalent
Becton Dickinson BDXAction date Sep 28, 2026
Device clearance (510(k)): Phasix ST Parastomal Hernia Mesh
On the record as Davol, Inc., A Subsidiary of C.R. Bard, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Incyte INCYAction date Sep 25, 2026
Drug approval: Atebrioz
New drug application approved. Active ingredient: Zilurgisertib
Align Technology ALGNAction date Sep 25, 2026
Device clearance (510(k)): Invisalign System
510(k) clearance, traditional: Substantially Equivalent
AbbVie ABBVAction date Sep 25, 2026
Drug approval: Juvmo
New drug application approved. Active ingredient: Tavapadon
Tempus AI TEMAction date Sep 25, 2026
Device clearance (510(k)): Tempus ECG-MR
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Sep 25, 2026
Drug approval: Olumiant
New use approved (efficacy supplement). Active ingredient: Baricitinib
Capsovision CVAction date Sep 25, 2026
Device clearance (510(k)): CapsoView (CVV); CapsoCloud (CLD)
510(k) clearance, traditional: Substantially Equivalent
Danaher Corporation DHRAction date Sep 25, 2026
Device clearance (510(k)): Xpert Respiratory Panel
On the record as Cepheid · 510(k) clearance, traditional: Substantially Equivalent
Becton Dickinson BDXAction date Sep 25, 2026
Device approval (PMA): Liverty TIPS Stent Graft
On the record as Bard Peripheral Vascular, Inc. · Premarket approval (PMA): SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Solventum SOLVAction date Sep 25, 2026
Device clearance (510(k)): 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
510(k) clearance, traditional: Substantially Equivalent
Orthopediatrics KIDSAction date Sep 24, 2026
Device clearance (510(k)): Pediatric Nailing Platform Femur
510(k) clearance, traditional: Substantially Equivalent
Zimmer Biomet ZBHAction date Sep 24, 2026
Device clearance (510(k)): OsseoFit Stemless Shoulder System
510(k) clearance, special: Substantially Equivalent
Carlsmed CARLAction date Sep 24, 2026
Device clearance (510(k)): corra® cervical plating system
510(k) clearance, traditional: Substantially Equivalent
Merck MRKAction date Sep 24, 2026
Drug approval: Welireg
New use approved (efficacy supplement). Active ingredient: Belzutifan
Zimmer Biomet ZBHAction date Sep 23, 2026
Device clearance (510(k)): G7® Acetabular System
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Sep 23, 2026
Drug approval: Onswik
Biologic approved. Active ingredient: Insulin Efsitora Alfa-Gobe
Abbott Laboratories ABTAction date Sep 23, 2026
Device clearance (510(k)): Anti-HCV Next
510(k) clearance, traditional: Substantially Equivalent
Si-Bone SIBNAction date Sep 23, 2026
Device clearance (510(k)): iFuse Granite Onyx Implant System
510(k) clearance, traditional: Substantially Equivalent
Danaher Corporation DHRAction date Sep 21, 2026
Device clearance (510(k)): Access NT-proBNP
On the record as Beckman Coulter, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Merck MRKAction date Sep 21, 2026
Drug approval: Winrevair
New use approved (efficacy supplement). Active ingredient: Sotatercept-Csrk
Trisalus Life Sciences TLSIAction date Sep 21, 2026
Device clearance (510(k)): TriSalus TriNav Advance Infusion System
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Sep 18, 2026
Drug approval: Verzenio
New use approved (efficacy supplement). Active ingredient: Abemaciclib
Baxter International BAXAction date Sep 18, 2026
Drug approval: Rocuronium Bromide
On the record as BAXTER HLTHCARE CORP · Generic drug approved. Active ingredient: Rocuronium Bromide
ICU Medical ICUIAction date Sep 18, 2026
Device clearance (510(k)): NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Sep 18, 2026
Drug approval: Inluriyo
New use approved (efficacy supplement). Active ingredient: Imlunestrant Tosylate
Abbott Laboratories ABTAction date Sep 17, 2026
Device clearance (510(k)): EnSite X EP System
On the record as Abbott Medical · 510(k) clearance, traditional: Substantially Equivalent
Stryker Corporation SYKAction date Sep 17, 2026
Device clearance (510(k)): Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke E…
510(k) clearance, special: Substantially Equivalent
Johnson & Johnson JNJAction date Sep 17, 2026
Device clearance (510(k)): HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
On the record as Ethicon Endo-Surgery, LLC · 510(k) clearance, traditional: Substantially Equivalent
Anika Therapeutics ANIKAction date Sep 17, 2026
Device clearance (510(k)): Integrity Retractable Implant Inserter (6000127)
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Sep 17, 2026
Device clearance (510(k)): Protégé EverFlex Self-expanding Peripheral Stent System
510(k) clearance, special: Substantially Equivalent
Ceribell CBLLAction date Sep 16, 2026
Device clearance (510(k)): Ceribell EEG Analysis Software
510(k) clearance, traditional: Substantially Equivalent
Astrazeneca AZNAction date Sep 16, 2026
Drug approval: Truqap
New use approved (efficacy supplement). Active ingredient: Capivasertib
GE HealthCare GEHCAction date Sep 16, 2026
Device clearance (510(k)): EchoPAC Software Only / EchoPAC Plug-in (v211)
On the record as GE Medical Systems Ultrasound and Primary Care Diagnostics · 510(k) clearance, traditional: Substantially Equivalent
Treace Medical Concepts TMCIAction date Sep 15, 2026
Device clearance (510(k)): TMC Implant Fixation System
510(k) clearance, special: Substantially Equivalent
Medtronic MDTAction date Sep 15, 2026
Device clearance (510(k)): LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
On the record as Covidien, LLC · 510(k) clearance, traditional: Substantially Equivalent
Astrazeneca AZNAction date Sep 14, 2026
Drug approval: Tagrisso
New use approved (efficacy supplement). Active ingredient: Osimertinib Mesylate
Becton Dickinson BDXAction date Sep 14, 2026
Device clearance (510(k)): BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
510(k) clearance, traditional: Substantially Equivalent
Scholar Rock Holding SRRKAction date Sep 11, 2026
Drug approval: Isembyld
Biologic approved. Active ingredient: Apitegromab-Mstn
Beta Bionics BBNXAction date Sep 11, 2026
Device clearance (510(k)): iLet Dosing Decision Software
510(k) clearance, traditional: Substantially Equivalent
Baxter International BAXAction date Sep 11, 2026
Drug approval: Metoclopramide Hydrochloride
On the record as BAXTER HLTHCARE CORP · Generic drug approved. Active ingredient: Metoclopramide Hydrochloride
Smith & Nephew SNNAction date Sep 11, 2026
Device clearance (510(k)): RENASYS DYNAFLOW Kit (66807741)
510(k) clearance, traditional: Substantially Equivalent
Beta Bionics BBNXAction date Sep 11, 2026
Device clearance (510(k)): Mint ACE Pump
510(k) clearance, traditional: Substantially Equivalent
Boston Scientific BSXAction date Sep 11, 2026
Device clearance (510(k)): SpaceOAR Flex System
510(k) clearance, traditional: Substantially Equivalent
Pharming Group PHARAction date Sep 11, 2026
Drug approval: Joenja
New use approved (efficacy supplement). Active ingredient: Leniolisib Phosphate
Biofrontera BFRIAction date Sep 9, 2026
Drug approval: Ameluz
New use approved (efficacy supplement). Active ingredient: Aminolevulinic Acid Hydrochloride
Smith & Nephew SNNAction date Sep 8, 2026
Device clearance (510(k)): LANDMARK Total Knee System
510(k) clearance, traditional: Substantially Equivalent
Shoulder Innovations SIAction date Sep 8, 2026
Device clearance (510(k)): N22 Offset Humeral Head
510(k) clearance, traditional: Substantially Equivalent
Amneal Pharmaceuticals AMRXAction date Sep 8, 2026
Recall, Class II: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-…
Defective Container; packets were found to be either empty or partially full.
Intuitive Surgical ISRGAction date Sep 8, 2026
Device clearance (510(k)): da Vinci Surgical System, Model IS5000
510(k) clearance, traditional: Substantially Equivalent
Dentsply Sirona XRAYAction date Sep 4, 2026
Device clearance (510(k)): Surgical and Prosthetic Trays
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Sep 4, 2026
Device clearance (510(k)): ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Auto…
510(k) clearance, traditional: Substantially Equivalent
Pfizer PFEAction date Sep 4, 2026
Recall, Class II: Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL…
Lack of Assurance of Sterility
Astrazeneca AZNAction date Sep 4, 2026
Drug approval: Etcamah
New drug application approved. Active ingredient: Camizestrant
Johnson & Johnson JNJAction date Sep 4, 2026
Device clearance (510(k)): ATTUNE Revision Knee System
On the record as Depuy Orthopaedics, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Boston Scientific BSXAction date Sep 3, 2026
Device clearance (510(k)): Rezum System
510(k) clearance, traditional: Substantially Equivalent
Kraft Heinz KHCAction date Sep 3, 2026
Recall, Not Yet Classified: Heinz Real - Vraie Mayonnaise, 12.5ml single serving packet, 500 packets per case, case code 57000 06672
undeclared ingredients including but not limited to mustard
GE HealthCare GEHCAction date Sep 2, 2026
Device clearance (510(k)): Vivid Explorer/Vivid Advanced/Vivid Focus
On the record as GE Medical Systems Ultrasound and Primary Care Diagnostics · 510(k) clearance, traditional: Substantially Equivalent
Anika Therapeutics ANIKAction date Sep 2, 2026
Device clearance (510(k)): HYALOMATRIX
510(k) clearance, traditional: Substantially Equivalent
Modular Medical MODDAction date Sep 2, 2026
Device clearance (510(k)): Pivot Insulin Delivery System
510(k) clearance, traditional: Substantially Equivalent
GE HealthCare GEHCAction date Sep 1, 2026
Device clearance (510(k)): Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
510(k) clearance, traditional: Substantially Equivalent
Supernus Pharmaceuticals, Inc. SUPNAction date Aug 31, 2026
Recall, Class III: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, K…
Failed dissolution specifications.
Amneal Pharmaceuticals AMRXAction date Aug 28, 2026
Recall, Class II: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b…
Defective Delivery System: Possibility of no medication in the prefilled pen.
GE HealthCare GEHCAction date Aug 28, 2026
Device clearance (510(k)): Carescape Canvas 1000; Carescape Canvas Smart Display
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Aug 28, 2026
Device clearance (510(k)): LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
510(k) clearance, special: Substantially Equivalent
Johnson & Johnson JNJAction date Aug 28, 2026
Drug approval: Stelara
On the record as JANSSEN BIOTECH · New use approved (efficacy supplement). Active ingredient: Ustekinumab
Eli Lilly LLYAction date Aug 27, 2026
Drug approval: Mounjaro
New use approved (efficacy supplement). Active ingredient: Tirzepatide
Stereotaxis STXSAction date Aug 27, 2026
Device clearance (510(k)): GenesisX RMN
510(k) clearance, special: Substantially Equivalent
Gilead Sciences GILDAction date Aug 27, 2026
Drug approval: Bixlenvo Sunlenca Starter Pack (Copackaged)
New drug application approved. Active ingredient: Bictegravir Sodium, Lenacapavir Sodium, Lenacapavir Sodium
Gilead Sciences GILDAction date Aug 27, 2026
Drug approval: Sunlenca
New use approved (efficacy supplement). Active ingredient: Lenacapavir Sodium
Gilead Sciences GILDAction date Aug 27, 2026
Drug approval: Bixlenvo
New drug application approved. Active ingredient: Bictegravir Sodium, Lenacapavir Sodium
Gilead Sciences GILDAction date Aug 27, 2026
Drug approval: Sunlenca
New use approved (efficacy supplement). Active ingredient: Lenacapavir Sodium
Eli Lilly LLYAction date Aug 27, 2026
Drug approval: Mounjaro
New use approved (efficacy supplement). Active ingredient: Tirzepatide
ResMed| RMDAction date Aug 27, 2026
Device clearance (510(k)): EasyCare Tx 2
510(k) clearance, traditional: Substantially Equivalent
Viatris VTRSAction date Aug 26, 2026
Recall, Class II: Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institu…
On the record as Mylan Pharmaceuticals Inc · Failed Dissolution Specifications
Boston Scientific BSXAction date Aug 26, 2026
Device clearance (510(k)): LithoVue Elite Digital Flexible Ureteroscope System
510(k) clearance, traditional: Substantially Equivalent
Revolution Medicines RVMDAction date Aug 26, 2026
Drug approval: Rasonque
New drug application approved. Active ingredient: Daraxonrasib
Bioventus BVSAction date Aug 26, 2026
Device clearance (510(k)): StimTrial Neuromodulation System
510(k) clearance, special: Substantially Equivalent
Sony Group SONYAction date Aug 26, 2026
Device clearance (510(k)): OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Aug 26, 2026
Drug approval: Zepbound
New use approved (efficacy supplement). Active ingredient: Tirzepatide
Zimmer Biomet ZBHAction date Aug 24, 2026
Device clearance (510(k)): Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
On the record as Biomet Orthopedics, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Boston Scientific BSXAction date Aug 24, 2026
Recall, Class I: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Johnson & Johnson JNJAction date Aug 24, 2026
Drug approval: Imaavy
On the record as JANSSEN BIOTECH · New use approved (efficacy supplement). Active ingredient: Nipocalimab-Aahu
Medtronic MDTAction date Aug 21, 2026
Device clearance (510(k)): Affera Integrated Mapping System
510(k) clearance, special: Substantially Equivalent
Boston Scientific BSXAction date Aug 21, 2026
Device clearance (510(k)): AVVIGO+ Multi-Modality Guidance System
510(k) clearance, traditional: Substantially Equivalent
Abbott Laboratories ABTAction date Aug 20, 2026
Recall, Class II: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par…
On the record as Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Abbott Laboratories ABTAction date Aug 20, 2026
Recall, Class II: Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-10…
On the record as Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Becton Dickinson BDXAction date Aug 20, 2026
Recall, Class II: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with soft…
On the record as Bard Peripheral Vascular Inc · Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…
Abbott Laboratories ABTAction date Aug 20, 2026
Recall, Class II: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part…
On the record as Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Abbott Laboratories ABTAction date Aug 20, 2026
Recall, Class II: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fish…
On the record as Alere San Diego, Inc. · hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
ICU Medical ICUIAction date Aug 20, 2026
Recall, Class II: CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-76…
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or…
