BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    AMER. PHARMASEAL NO TOUCH SATIN CATHET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PS MEDICAL NEUROSURGICAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    BNX Fine Needle Aspiration System

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    BIOPATCH 3150

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FRO·November 15, 2012

    MICRO RECIPROCATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HWE·August 24, 2010

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014