BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    PCXX VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131463·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...

    BIO-MODULAR / BI-POLAR SHOULDER

    FDA UDI
    Biomet Orthopedics, LLC·00880304002388·

    Oticon

    FDA UDI
    Oticon A/S·05707131234063·GET, BTE P 13 STG

    ISOGRAY TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIATRONIC V3D CALCIUM SCORING

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    PAGEWRITER TC 20 CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017

    CONTINUUM TRABECULAR METAL SHELL

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code LZO·May 9, 2013

    ASR ACETABULAR CUPS 52

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

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 11, 2008

    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