BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Oticon

    FDA UDI
    Oticon A/S·05707131233806·GET, BTE 13 STG

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131395·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...

    STELLARTECH COAGULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CURVE IMAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    GREENLIGHT HPS FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 9, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Death ·MPRI·Product code LWS·September 24, 2014

    DLT TS CER HD 12/14 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·May 20, 2011

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025