BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OnBrace Crown LR8 (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199013380·

    BIRMINGHAM HIPTM RESURFACING

    FDA UDI
    Smith & Nephew, Inc.·03596010503497·BHR HEAD CENTRE CHECK JIG SZ 38

    MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER

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

    COLLASORB COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 22, 2019

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 4, 2015

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    UNKNOWN KNEE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code NRA·July 9, 2015

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 8, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021