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.

169800510(k)
952PMA
33571Companies
12365Trials

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Latest Trends

During this period, 169800 medical devices received FDA 510(k) clearance and 952 devices received Premarket Approval (PMA) . Top categories: GEX (2782 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

IYN2026-10-16

Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K261585

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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-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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