BEUDAMED
    116 results · 29ms · Sources: EU EUDAMED, US FDA

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    NSTRAND IMPLANTATION KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809847789·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707060826·BUCCAL TUBES FOR TWIN ARCH

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400520240·Anterior Dome Osteotomy Guide, 52mm x 24mm

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code QBJ·October 10, 2024

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 2, 2014

    FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM)

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NFA·May 21, 2008

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 15, 2024

    RESOLUTE ONYX RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·February 21, 2025

    Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)

    FDA Enforcement
    Class II ·Ongoing·Covidien LP·November 6, 2024

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·July 5, 2024