BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    APTUS CANNULATED COMPRESSION SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169606166·SPACER 2133460 OLIF25 27MM 18 DEG 14X60

    HHM

    FDA UDI
    Oticon A/S·05707131261700·H100, BTE 13 WL 85 DBL HHM

    NOYES IRIS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896097858·NOYES IRIS SCISSORS ROUND HANDLE BLUNT SLIGHTLY...

    CHEETAH WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SYNERGY TISSUE MATRIX

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

    MENTOR

    FDA Adverse Event
    Injury ·MENTOR CORPORATION·Product code FWM·September 27, 2003

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 29, 2013

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011

    CROSS-CUT FISSURE CARBIDE BUR, TAPERED

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD., INSTRUMENTS DIVISION·Product code EJL·August 22, 2008

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015