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

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    MSK EXTREME MR SCANNER, MODEL AA5000

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 48mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025026·

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482139578·Symmetry Forceps; Coaptation Bipolar; 0.4 mm Ti...

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935100669·

    SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    NEXGEN LPS FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code NJL·April 24, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 21, 2019

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021