BEUDAMED
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    TAMPAX M PLASTIC TAMPONS, UNSCENTED

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

    Oticon

    FDA UDI
    Oticon A/S·05707131259790·RIA PRO, BTE 13 WL 85 DBL

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION

    FDA 510(k)
    FDA Unclassified ·Unknown

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·March 31, 2020

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 2, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·May 11, 2011

    HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE SA - SINGAPORE,·Product code FKX·August 21, 2008

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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