BEUDAMED
    24 results · 26ms · Sources: EU EUDAMED, US FDA

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    REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

    FDA 510(k)
    FDA Class 2 ·Immunology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091206·1.2mm x 8mm Fully Threaded Screw

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112080·Rasp, 8 and 10mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112080·Tap, Cannulated, 6.5 mm

    ESPIRT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    ULTRA DRIVE 6MM PLUG PULLER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

    EVIA DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·April 2, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·March 16, 2011

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES IMPLANTS S.A.·Product code JXG·April 18, 2008

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016