BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    Flash Ultrasound System 5100 Point of Care

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    Intersurgical Incorporated·05030267128228·FACEFIT NIV MASK WITH PORT SMALL

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776162740·REUSABLE IRRIGATION/SUCTION SYSTEM WITH DUAL HI...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515236004·Malis-Style Bipolar Forcep, 8.75" Titanium, Irr...

    CENOGENICS CORP.

    FDA registration
    CENOGENICS CORP.·15 products·🇺🇸 United States

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180156814·REUSABLE IRRIGATION/SUCTION SYSTEM WITH DUAL HI...

    Preference

    FDA UDI
    CTL Medical Corporation·00841732152670·7.2mm Polyaxial Triple-lead screw 30mm Green

    Preference 2

    FDA UDI
    SINTX Technologies, Inc.·M555287250030·ø7.2 Triple Lead Screw Assembly, 30mm

    NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT

    FDA Adverse Event
    Malfunction ·PERKINELMER, INC.·Product code QJR·March 5, 2021

    Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACTICOAT MOISTURE CONTROL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DR FOG TREATED SPONGE, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·October 28, 2021

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 14, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2011

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 26, 2013

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013