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

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    APEX SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVEREST Spinal System

    FDA UDI
    VB Spine LLC·10888857561212·Tapered Tap Size 5.5 mm

    SA FLOWABLE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING

    FDA 510(k)
    FDA Class 2 ·Dental

    VICRYL TAPE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·September 4, 2019

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 27, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 25, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 26, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 29, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·December 8, 2006

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    BIOSENSE WEBSTER, INC.

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC.·Product code DRF·June 10, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 21, 2008

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023