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

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    SONOSITE EDGE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABSOLUTE BI-POLAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304002371·

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664005627·FM CASUAL 20-30 KH CT L NA 1 EN FR ES

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...

    MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V.A.C. VERAFLO CLEANSE DRESSING SYSTEM

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

    LINEAR ST

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 18, 2023

    SYMBIQ 3.13 SINGLE C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 8, 2013

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC.·Product code MIH·August 12, 2008

    ASR UNI FEMORAL IMPL SIZE 47

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

    Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWT·February 23, 2004

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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 L131, ESSENTIO 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