BEUDAMED
    22 results · 33ms · Sources: EU EUDAMED, US FDA

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    GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00262131·

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019423·The ENDO CARRY-ON Procedure Kit contains all of...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026210·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    DARDIK CAROTID SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997

    APOGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·September 11, 2012

    UNKNOWN ANATOMICAL SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 22, 2016

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·March 13, 2023

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·March 10, 2023

    AXIUM NYLON HELICAL DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·March 13, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 12, 2014

    ELECSYS 2010 DISK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·February 8, 2008

    OXF UNI TIB TRAY SZ B RM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 17, 2021

    OXF TWIN-PEG CMNTD FEM LG PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 17, 2021

    INDIGO SYSTEM FLASH ASPIRATION CATHETER

    FDA Adverse Event
    Death ·PENUMBRA, INC.·Product code QEW·June 5, 2023

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025