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

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    Chagas Detect Plus Rapid Test

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IVD-GE02

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    21.3 INCH MONOCHROME LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 24, 2014

    SAFEPICO ASPIRATOR

    FDA Adverse Event
    Injury ·RADIOMETER MEDICAL APS·Product code JKA·May 13, 2011

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014