BEUDAMED
    16 results · 30ms · Sources: EU EUDAMED, US FDA

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    Talee, Talee PostOp

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    H-30 HOLMIUM LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OYC·March 28, 2017

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    SISO II BULLET NOSE DISSECTING FORCEPS

    FDA Adverse Event
    Malfunction ·ACMI CANADA, INC.·Product code HCZ·November 7, 2008

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 15, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025