BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    SmarTemp X1

    FDA 510(k)
    FDA Class 2 ·Dental

    PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACTIVE WASTE GAS SCAVENGER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 6, 2014

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 6, 2014

    BD Microtainer SST- Amber Part/Catalog Number: 365978

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 14, 2013

    AXIUM PGLA DETACHABLE COIL

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·August 4, 2011

    TOWEL OR 17X24IN BLUE 2PK X-RAY DETECTAB

    FDA Adverse Event
    Malfunction ·JIANERKANG MEDICAL DRESSING CO. LTD·Product code FRL·October 16, 2020

    STEALTHSTATION S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 2, 2020

    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020