BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI

    Edgewise Individual Root Torque

    FDA UDI
    TP ORTHODONTICS INC·00192029027745·0.41mm (.016")

    Tecomet

    FDA UDI
    TECOMET INC.·00841435121409·COBB GOUGE SLIGHT CURVE

    CADSTREAM VERSION 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Assurance Alar / Nasal SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929041055·SA ALIF, 24Dx32Wx16H 8°

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929042403·SA ALIF, 24Dx32Wx16H 25°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929037232·ALIF, 24Dx32Wx16H, 20°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929037188·ALIF, 24Dx32Wx16H, 14°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929037133·ALIF, 24Dx32Wx16H, 8°

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929041093·SA ALIF, 24Dx32Wx16H 14°

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929041123·SA ALIF, 24Dx32Wx16H 20°

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 7, 2008

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 18, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025