Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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.

169700510(k)
951PMA
33543Companies
11925Trials

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Latest Trends

During this period, 169700 medical devices received FDA 510(k) clearance and 951 devices received Premarket Approval (PMA) . Top categories: GEX (2779 devices), GEI (2223 devices), LLZ (2151 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

View all FDA 510(k) Clearances

Latest PubMed Research

Recent medical device publications from PubMed / NCBI

FDA Medical Device Recalls

Latest recalls and safety alerts from FDA

Class IIZ-3183-2026

REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL

Reason Reusable access port system may crack or seperate during use.

Firm Stryker Sustainability Solutions

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Class IIZ-0004-2027

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LI

Reason Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Prod

Firm ASP Global, LLC.

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Class IIZ-3191-2026

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000

Reason Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically tra

Firm Datex-Ohmeda, Inc.

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Class IIZ-3192-2026

Et Control, Software option for anesthesia gas machine to achieve and maintain t

Reason Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically tra

Firm Datex-Ohmeda, Inc.

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Class IZ-3151-2026

Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;

Reason Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules

Firm AVID Medical, Inc.

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Class IZ-3228-2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1070

Reason Potential fire hazard involving the hand control pendant and associated wiring used with affected be

Firm Medline Industries, LP

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