BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Discectomy Set

    FDA UDI
    SPINEOLOGY INC.·M7403030067·Ball Probe #2

    SILMET LTD.

    FDA registration
    SILMET LTD.·6 products·🇮🇱 Israel

    Trinity Biotech

    FDA UDI
    PRIMUS CORPORATION·05391516748636·Hemoglobin A1c assay, PDQ Wash Reagent

    CALEO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACROMED

    FDA Adverse Event
    Injury ·UNK·Product code MCV·October 30, 2003

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    PROBE 8225101 5PK STD PRASS FLUSH TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·April 2, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011

    TRIDENT HEMISPHERICAL CLUSTER 56MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·April 15, 2008

    ADJUSTABLE CERVICAL DISTRACTOR-LEFT

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code LXH·August 8, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021