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

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    TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50911420·

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066251·

    7LT4 Ultrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088914·

    AUDIO TECHNOLOGIES S:R.1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AQUARIUS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·June 16, 1997

    GAS MODULE II

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 9, 2011

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 31, 1997

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·January 7, 1998

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·August 12, 1997

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 9, 1997

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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