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

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    First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KENSEY NASH MACROPORE SHIELD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HYBRID GRAFT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·July 22, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2015

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

    MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021