BEUDAMED
    16 results · 33ms · Sources: EU EUDAMED, US FDA

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    CDI BLOOD PARAMETER MONITORING SYSTEM 500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    E.P.T. PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·July 2, 2013

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·October 1, 2014

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 1, 2013

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·June 8, 2011

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

    MPACT ACETABULAR SHELL Ø46 TWO-HOLES

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·March 3, 2017

    MPACT FLAT PE HC LINER Ø28/B

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·January 8, 2016

    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015