BEUDAMED
    16 results · 32ms · Sources: EU EUDAMED, US FDA

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    MEDART DIODE LASER SYSTEM & ACCESSORIES

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III

    SUPRACHROME+ (500g)

    FDA UDI
    ARGEN CORPORATION, THE·D818110243·Base metal alloy

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707097501·BKT 43 INTERACTIVE SL 22 T-6 A+3 BH

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037307298·GLENOID RESURFACING REAMER Ø43 mm/30 /AO

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

    TRI-FIT FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUINTEX CERVICAL PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP.·Product code MKJ·May 20, 2011

    ACCU-CHEK ADVANTAGE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·August 14, 2008

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019

    Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025