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

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    SOLO-CARE BRAND HARD SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MediClear™ PreOp

    FDA UDI
    Covalon Technologies Ltd·00825439012871·Antimicrobial Self-Adherent Silicone Film Drape...

    CovaView™ IV 6x7

    FDA UDI
    Covalon Technologies Ltd·00825439013502·Transparent IV Dressing (Cover Dressing)

    MediClear™ Scar 6x7

    FDA UDI
    Covalon Technologies Ltd·00825439012291·Self-Adherent Silicone Film Dressing for Scar Care

    Tooth Tone

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730014825·NiTi Coated Upper 16x22 10 archwires per pack

    KONG-C VBR, Screw, M6 x 7 mm

    FDA UDI
    icotec AG·07640172550038·KONG-C VBR, Screw, M6 x 7 mm

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209420666·FlowLogic Assert Shaping File 25/.04, 21mm

    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·August 15, 2024

    ABL90 FLEX

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·February 12, 2015

    ABL90 FLEX

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·February 12, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 2, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 21, 2008

    PRODIGY LG STAT SHT LT 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018

    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020