BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    ROSEALAE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517121714·SpheRx® PPS Lock Screw, 5.5mm Rod

    ReliOn™ Premier BLU Basic Meter

    FDA UDI
    WAL-MART STORES, INC.·00194346136650·The ReliOn Premier BLU Blood Glucose Monitoring...

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551198971·Indirect Laryngeal Forceps, 17 cm

    ReliOn™ Premier BLU Basic Meter (or Monitoring System)

    FDA UDI
    WAL-MART STORES, INC.·00681131169806·The ReliOn Premier BLU Blood Glucose Monitoring...

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470004472·PERC DLR SPINE WAND SURGICAL DEVICE

    SpineWand

    FDA UDI
    MORGAN STEER ORTHOPAEDICS LIMITED·05060696460002·Perc DLR Convenience Pack Inc 17 gauge 6” Crawf...

    8.2MHZ PENCIL PROBE 840

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787023619·

    Acucy Influenza A&B Test with the Acucy System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    M2A 38MMX52MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 30, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

    LIGACLIP MCA SMALL APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDO·January 30, 2008

    CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code GEI·November 15, 2017

    CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code GEI·November 15, 2017

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·August 21, 2020

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021