BEUDAMED
    12 results · 26ms · 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.

    PHADEBACT STREP D TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209100514·KIT, USMC COMBAT LIFE SAVING - COY

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306809668·Luer-to-Luer Transfer, 2mm

    AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

    FDA 510(k)
    FDA Class 2 ·Radiology

    KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    FDA Adverse Event
    Injury ·VERTIFLEX INC.·Product code NQO·March 21, 2020

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 8, 2014

    FLEXION PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·October 12, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022