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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.

169956510(k)
953PMA
33797Companies
13124Trials

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Latest Trends

During this period, 169956 medical devices received FDA 510(k) clearance and 953 devices received Premarket Approval (PMA) . Top categories: GEX (2787 devices), GEI (2225 devices), LLZ (2155 devices). Most active applicants: Abbott Laboratories (883), Siemens Medical Solutions USA, Inc. (733), Bd Becton Dickinson Vacutainer Systems Preanalytic (632).

Latest FDA PMA Approvals

Most recent Premarket Approval decisions

Latest FDA 510(k) Clearances

Most recent medical device clearances

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Device Classification Directory

Browse FDA product codes by medical specialty

Latest PubMed Research

Recent medical device publications from PubMed / NCBI

FDA Medical Device Recalls

Latest recalls and safety alerts from FDA

Class IIZ-0285-2027

OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 7

Reason Affected leads require additional engineering evaluation due to complaints regarding difficulty in a

Firm Medtronic, Inc.

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Class IIZ-0164-2027

TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.

Reason Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the

Firm Howmedica Osteonics Corp.

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Class IIZ-0145-2027

Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2

Reason Firmware issue may result in intermittent loss or degradation of powered functionality when paired w

Firm Ferno-Washington Inc

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Class IIZ-0232-2027

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Numbe

Reason The product is defective due to insufficient UV curing of the hydrophilic coating which is present o

Firm Boston Scientific Cork, Ltd.

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Class IIZ-0166-2027

Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.

Reason Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the

Firm Howmedica Osteonics Corp.

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Class IIZ-0085-2027

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2

Reason Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal

Firm Stryker Sustainability Solutions

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