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

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    FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Clement Clarke International

    FDA UDI
    CLEMENT CLARKE INTERNATIONAL LIMITED·05023323029478·ONE WAY VALVE EXP (200)

    All Flow Valved Ex.Mthpc.

    FDA UDI
    ALLIANCE TECH MEDICAL INC·00384620000764·

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032607·CV / OPEN HEART PACK

    ArgenZ HT+ 98x20 C2

    FDA UDI
    ARGEN CORPORATION, THE·D818122064·Dental porcelain/ceramic restoration kit

    Logical PX-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215000448·

    RESORB X-G

    FDA 510(k)
    FDA Class 2 ·Dental

    BD FACS SAMPLE PREP ASSISTANT III (SPA III)

    FDA 510(k)
    FDA Class 2 ·Hematology

    VERSAFITCUP CC TRIO CUP 52

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·January 23, 2015

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 21, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·May 24, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·August 14, 2008

    IMPELLA CP

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code OZD·August 8, 2024

    IMPELLA CP

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code OZD·October 28, 2024

    IMPELLA 5.5

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code OZD·April 30, 2025

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020