BEUDAMED
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    SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    mambo™ modular cervical plate system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536164400·mambo bone screw, self-drilling, violet, Ø 3.5 ...

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 20, 2002

    PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BILLY BOY MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BLACKMAX-NEURO LOW PRESSURE

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 21, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 28, 2011

    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

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024