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FDA Medical Device Regulatory Records

Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search.

32464510(k)
941PMA
10427Companies
8200Trials

Latest Trends

During this period, 32464 medical devices received FDA 510(k) clearance and 941 devices received Premarket Approval (PMA) . Top categories: LLZ (802 devices), GEX (627 devices), GEI (581 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (178), Arthrex, Inc. (171).

Latest FDA PMA Approvals

Most recent Premarket Approval decisions

Latest FDA 510(k) Clearances

Most recent medical device clearances

ODP2026-07-17

Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM

Applicant Stryker Spine

K-Number K262061

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Latest PubMed Research

Recent medical device publications from PubMed / NCBI

FDA Medical Device Recalls

Latest recalls and safety alerts from FDA

Class IIZ-2623-2026

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Reason Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Firm Remel, Inc

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Class IIZ-2609-2026

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTO

Reason Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of le

Firm Medline Industries, LP

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Class IIZ-2729-2026

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral o

Reason Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103,

Firm Orthofix U.S. LLC

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Class IIZ-2646-2026

RayCare 2024A SP1. Oncology Information Systems.

Reason Beam set delivery note issues in which there is potential data loss if the beam set delivery note is

Firm RAYSEARCH LABORATORIES AB

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Class IIZ-2656-2026

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609

Reason Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer

Firm Bard Access Systems, Inc.

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Class IIZ-2725-2026

Rapid Refill Continuous Injection System, UPN M00566001

Reason Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is

Firm Boston Scientific Corporation

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