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.

169749510(k)
951PMA
33556Companies
12249Trials

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Latest Trends

During this period, 169749 medical devices received FDA 510(k) clearance and 951 devices received Premarket Approval (PMA) . Top categories: GEX (2781 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-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 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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Class IIZ-3309-2026

Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T

Reason When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM fo

Firm Philips North America

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Class IIZ-0022-2027

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-L

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-0037-2027

Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUA

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-3247-2026

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: C

Reason Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesi

Firm Olympus Corporation of the Americas

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