BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS

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

    CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES

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

    PROVIDENCE MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 14, 2024

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 24, 2013

    AUTOPULSE® LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·September 30, 2014

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2011

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·December 10, 2013

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019