BEUDAMED
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    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIAL INSERT 32/62

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489528101·

    Smith and Nephew

    FDA UDI
    Provision·B504OM2528100·

    Smith and Nephew

    FDA UDI
    Provision·00810041639806·

    Q-FIX

    FDA UDI
    Smith & Nephew, Inc.·00885556724651·Q-FIX REUSABLE 2.8MM PATHFINDER OBTURATOR

    SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeVilbiss DV6WM Wireless Modem

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Exactech, Inc.·10885862552358·TRIAL, TIBIAL SPACER, SIZE 3-4.5, 10mm

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 1, 2024

    DISPOSABLE KIT 2.8MM SHOULDER Q-FIX

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code LXH·November 16, 2023

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 4, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 29, 2013

    DISPOSABLE KIT 2.8MM SHOULDER Q-FIX

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code LXH·May 10, 2021

    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

    FDA Enforcement
    Class II ·Terminated·OPTI Medical Systems, Inc·October 30, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014