BEUDAMED
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    EVA SELECT DIGITAL DENTAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TRILAMINATE DRAPES/TIBURON

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

    EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·October 5, 2022

    SERVO-I

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 14, 2011

    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