BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    Dornier Ureteral Stent

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cadwell Guardian

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067102893·24-Channel Omni Amplifier

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306812354·Cottle Nasal Speculum, Partial Internal Groove,...

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·December 19, 2018

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·January 3, 2019

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180543344·Short ALIF Bullet Distractor 12mm Anterior

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402801·Broach, Tibial Cone S Full

    TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC

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

    DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PGA

    FDA Adverse Event
    Malfunction ·CP MEDICAL·Product code GAM·December 11, 2019

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·July 13, 2018

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·March 17, 2016

    GALAXY G3 MINI 1MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 21, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 1, 2024

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·October 6, 2008

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ? REG. # 8010379·Product code KWA·June 26, 2013

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 20, 2011

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023