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

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    GEM Premier ChemSTAT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517504081·XLIF Corp Blade, 90mm Lung Retractor Nrw

    REAMER HEAD 9.0mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000627·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197032988·Shortbent Ligature Scissor 9.0 cm...

    GLOBAL CAP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295383833·GLOBAL CAP TRAY 2 - QC REAMERS

    GLOBAL CAP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105176·GLOBAL CAP CASE & TRAY COMPLETE

    OPTION-VF URINARY CATHETER, FV14218

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GLB BENECHECK PREMIUM GLU MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·September 17, 2018

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·September 17, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 4, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·August 10, 2011

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 12, 2013

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    XP-XP Tibial Tray - Interlok 69 mm Item # 195754

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018