BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213036291·Coupling Treatment Tube for 6F Flexibles (25)

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089475643·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089475681·

    QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 6, 2013

    SOL SYS 10/15.0 R LRG STAT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·September 23, 2014

    UNKNOWN DEPUY HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 13, 2011

    IMMULITE® 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024

    IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 1, 2017

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

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

    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