BEUDAMED
    17 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    SCALPFIX CLIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122190·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187020·Battalion, LLIF Trial, 10°, 22 mm Wide, 19 mm X...

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader

    WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CHALLENGER DIRECT COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    S4 IMPLANTS

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KWP·August 29, 2008

    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 25, 2020

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

    ALLURA XPER FD10

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 1, 2011

    BTK TURBOHAWK

    FDA Adverse Event
    Injury ·COVIDIEN·Product code MCW·November 11, 2019

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·November 11, 2019

    SPIDER FX

    FDA Adverse Event
    Injury ·COVIDIEN·Product code NTE·November 11, 2019

    CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    Leica ARveo and M530 OH6 microscope systems.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·June 24, 2020

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018