BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Zeta Cranial Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464032433·SONIC RADIANT 80 MNR T BR/TP

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101162·DLEK CORNEAL DISSECTOR, VAULTED

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRYKER PAINPUMP2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 29, 2014

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 12, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 16, 2013

    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

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025