BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    Applanation tonometer AT-1

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ARSTASIS ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNGO MULTIMODALITY WORKPLACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

    UVSL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS MEDICAL·Product code MHX·September 22, 2008

    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·December 7, 2016

    0.76MM DRILL BIT/STRYKER J-LATCH/WITH 5MM STOP/44.5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·November 17, 2016

    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

    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