BEUDAMED
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    BEE PLIF Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280385·0.9MM DOUBLE TROCAR TIP MINI KOMPRESSOR

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113447·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...

    POWDER-FREE VINYL EXAM GLOVE, YELLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIOGEL (R) INDICATOR (R) UNDERGLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MONARCH PLATFORM

    FDA Adverse Event
    Injury ·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·August 8, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 8, 2013

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    OPTIPAC 80 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·July 7, 2022

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023