BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    PROCEDURAL STRECHER WITH INTELLIDRIVE P8000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Biosens cartridges Light Pink

    FDA UDI
    PERFLEX LTD·07290110501525·box of 6 identical cartridges sealed in a vacuu...

    T-Crystal cartridges Light Pink

    FDA UDI
    PERFLEX LTD·07290110500122·Box of 6 identical cartridges sealed in aluminu...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180163881·Lockhart-Mummery Fistula Probe, Slight Curve

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158213715·PROBE LOCKHART-MUMMERY FISTULA SLIGHT CURVE 6.5"

    Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837089931·

    T-Crystal cartridges Light Pink

    FDA UDI
    PERFLEX LTD·07290110506025·5 identical cartridges sealed in a vacuum bag ;...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857531161·Screwdriver, Split Tip Size 434.3

    MEDIGROUP CATHETER EXTENDER/REPAIR KIT

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

    GOLIFE NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    EXP SINGLE SET SCREW 5.5 SS

    FDA Adverse Event
    DEPUY SPINE, INC.·Product code KWP·April 6, 2011

    HEARTMATE APICAL CORING KNIFE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 17, 2020

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019