BEUDAMED
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    UNEXEF-38G ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPTURA HOT BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    SENSIA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011

    STOCKERT RF GENERATOR

    FDA Adverse Event
    Injury ·STOCKERT GMBH·Product code DRF·August 21, 2008

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015