BEUDAMED
    22 results · 28ms · 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.

    WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889166·SCREW 3120314 4.0 X 14 SELF TAP VAR

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994239662·SCREW 3120314 4.0 X 14 SELF TAP VAR

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243738·UNITY KNEE™ PS-C INSERT - Size 3 x 14mm

    ARGENCO 60S

    FDA UDI
    ARGEN CORPORATION, THE·D818120314·Gold based noble metal

    HemoCue® Plasma/Low Hb Photometer

    FDA UDI
    Hemocue AB·07311091203144·HemoCue Plasma/Low Hb Photometer mg/dL

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113171·PS Insert, Size 3 x 14mm

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319703816·Walter (Hunter) Splinter Forceps 4-1/4" (10.6cm...

    DIGI-PRO TENS, MODEL WL-2204 AND WL-2205

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IMNS MEDACTA NAVIGATION SYSTEM,33.221000US

    FDA 510(k)
    FDA Class 2 ·Neurology

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 26, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 1, 2011

    ARCHITECT B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·October 14, 2013

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015