BEUDAMED
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    BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    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

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295245353·P.F.C. SIGMA RP CURVED TIBIAL INSERT TRIAL SZ 3...

    MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014

    KANG EPMP ADP W/ 4 PWR ADP PLG

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·January 24, 2013

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code LOX·January 18, 2011