BEUDAMED
    16 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    DISPOSABLE PATIENT CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909106452·REVELATION DIAMOND 852-010C - 5 PACK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756371131·BASIC PAIN PACK

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450216705·

    AT HOME DRUG TEST, MODEL 9063 T

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 19, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 2, 2014

    GALAXY G3 6MM X 20CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 XSFT 3MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 8MM X 24CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019

    GALAXY G3 7MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 6MM X 10CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 6MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022