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

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    HEAT AND MOISTURE EXCHANGER FILTER (HME)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207022993·SEALING CONE Ø 12-15MM for subcutaneous fascia...

    HYDROSET

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154275021·15CC HYDROSET INJECTABLE CEMENT

    MINI-HALO CO2 LASER SYSTEM

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

    FIX-C 3D Ti ACIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNK CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·February 5, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 1, 2010

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 18, 2014

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018

    ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019

    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code GXP·July 30, 2013

    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.

    FDA Enforcement
    Class II ·Terminated·Stryker Craniomaxillofacial Division·September 4, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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