BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    EkoSonic Endovascular Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVO Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331184215·Coaptation Bipolar Forceps, 0.5 mm tip, 4-1/4" ...

    sentida 5

    FDA UDI
    WISSNER-BOSSERHOFF GmbH·04050621100449·Basic electric home bed

    SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO THE CROSSER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MELODY TRANSCATHETER PULMONARY VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·August 26, 2019

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 21, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 14, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 25, 2011

    SMALLBORE TRIFUSE EXT. SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·August 16, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·December 6, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·December 10, 2019

    SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

    FDA Enforcement
    Class II ·Ongoing·WISSNER-BOSSERHOFF GMBH·November 20, 2024

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016