BEUDAMED
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    UHR Bipolar Implants, Restoration GAP II Implants

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIMON NITINOL FILTER 2220

    FDA Adverse Event
    Injury ·NITINOL MEDICAL TECHNOLOGIES, INC.·Product code DTK·July 25, 1997

    SIMON NITINOL FILTER 2220

    FDA Adverse Event
    Malfunction ·NITINOL MEDICAL TECHNOLOGIES, INC.·Product code DTK·July 25, 1997

    SIGN IM NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GUAVA II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIM·August 25, 2011

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024