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

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    VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DI-CHEM, INC.

    FDA registration
    DI-CHEM, INC.·1 product·🇺🇸 United States

    PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE

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

    TANDA MAX

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

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

    TRUWAVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 28, 2011

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

    1823260-2015-03682

    FDA Adverse Event
    Malfunction ·June 19, 2015

    COBAS 8000 E602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 13, 2015

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    COBAS E411 RACK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 12, 2015

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    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