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

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    AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    8200 VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00817136020105·8286C INF/BAL VLV LESS HCNTRL

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CYNOSURE PHOTOGENICA ER

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

    V.A.C.ULTA THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 23, 2021

    BD VENFLON¿ IV CANNULA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·April 19, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 14, 2013

    MICRO-MINIATURE LIGHT WIRE CUTTER

    FDA Adverse Event
    Malfunction ·GAC INTERNATIONAL·Product code EJB·April 29, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 12, 2008

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021