BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    RAPID GRAM-POSITIVE ID SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Wireless Digital Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013

    UNKNOWN

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·January 11, 2011

    ADULT 8.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code BTR·July 28, 2014

    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 6, 2016