BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N

    FDA 510(k)
    FDA Class 1 ·Dental

    Spider Limited Wrist Fusion System

    FDA UDI
    Smith & Nephew, Inc.·00885556834695·SPIDER TITANIUM 2.8/12MM BONE SCREW

    Integra® Spider™ Limted Wrist Fusion System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780064701·The Integra Spider Limited Wrist Fusion titaniu...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312797·STD TRIAL CUP FOR BOACH Ø32+12

    STERiLANCE Press2 Disposable Safety Lancet

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630132497·

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 16, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·April 28, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 4, 2021

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037317457·STANDARD TRIAL FIXED CUP FOR BROACH Ø32 +12

    IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EX-PRESS MINI GALUCOMA SHUNT

    FDA Adverse Event
    Injury ·OPTONOL, LTD·Product code KYF·April 11, 2013

    LAVEEN 10CC INFLATOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC, CORPORATE HEADQUARTERS·Product code MAV·April 8, 2011

    KIT 11.5FX16 CE MAHURKAR

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code MSD·June 18, 2008

    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

    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015