BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LateralALIF

    FDA UDI
    Nuvasive, Inc.·00887517840134·ALIF Pin, 160mm Anchoring

    VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RRT SHORT RAGWEED TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATLAS PLUS VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·February 21, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION - RENAL DIVISION·Product code KDJ·January 30, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·August 1, 2014

    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code MQP·November 19, 2009

    Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code MNI·February 2, 2010

    4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code KWQ·March 15, 2010