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

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    PREFILLED CATHETER INFLATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK112201·DD tempMED are pre-colored dental milling blank...

    T-Crystal cartridges Opaque Pink

    FDA UDI
    PERFLEX LTD·07290110506391·5 identical cartridges sealed in a vacuum bag ;...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857529939·Replaceable Tip

    CASPIAN® Spinal System

    FDA UDI
    VB Spine LLC·10888857216600·Rod Cutter Size 3.5 mm

    CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENCODE PATIENT SPECIFIC ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    BD LANCET 33GA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMK·May 26, 2020

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2019

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013

    CARELINK PERSONAL

    FDA Adverse Event
    Malfunction ·Product code OYC·September 23, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 3, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·May 8, 2023

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021