BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493944835·AVANOS* Double Needle Set

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651944839·

    ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    1.5T 16-CHANNEL HAND-WRIST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·June 21, 2002

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    DRILL, AO, STERILE ?4, 2X340MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 10, 2010

    AL-III W/FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    6.5MM DRILL BIT/CONICAL W/STOP

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·June 21, 2013

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 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 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