BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Wrinkle Treatment Device (JM2)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ESR-Vacuum tubes

    FDA UDI
    STRECK, INC.·00844509000006·1.2ml tri-sodium citrate blood collection tubes...

    Model 2403-60 Maestro Patient Transmit Coil

    FDA UDI
    Reshape Lifesciences Inc.·00857334004323·The Model 2403-60 Transmit Coil is a non-steril...

    Holder, Needle, TC, acc. DeBakey 18cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034066072·Holder, Needle, TC, acc. DeBakey 18cm ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023609·Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869604352·MOSS 100 Ti Rod, Ø4.5x360mm

    HEALTH KIOSK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMU128S, MODEL EX-NW-128S

    FDA 510(k)
    FDA Class 2 ·Neurology

    SURESTEP ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 18, 2002

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 24, 2022

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code LFR·March 29, 2007

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 1, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·July 18, 2013

    PROG VALVE CLYNDRICAL W PRECHA

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·July 15, 2020

    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

    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