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

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    GEO Bone Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNETEC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    GLENOID 48MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWT·October 27, 2014

    PEDICPROBE Ø3.7 W/SILIC HAND L240 F/PEDI

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXB·July 2, 2013

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Death ·COOK INC·Product code MIH·September 8, 2021

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021