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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.

169862510(k)
952PMA
33582Companies
13044Trials

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Latest Trends

During this period, 169862 medical devices received FDA 510(k) clearance and 952 devices received Premarket Approval (PMA) . Top categories: GEX (2784 devices), GEI (2224 devices), LLZ (2153 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

LJH2026-10-23

Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads

Applicant Poly Medicure Limited

K-Number K261670

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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-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-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-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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