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

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    THYMATRON 2000 ELECTROCONVULSIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377073389·RELINE C CoCr Rod, 3.5x120mm Straight

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105573·KATENA-VANNAS SCISSORS 10MM STRAIGHT

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937224·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938399·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939563·Percutaneous Transluminal Angioplasty Balloon C...

    SAF FIXATIVE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TEF/PLATINUM PISTON

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

    0001825034-2018-05646

    FDA Adverse Event
    Injury ·August 6, 2018

    ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY STANDARD OFFSE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 6, 2018

    UNKNOWN CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    CER BIOLOXD OPTION HD 40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 6, 2018

    CER OPTION TYPE 1 TPR SLEVE -3

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·October 12, 2018

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code BTR·January 31, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 18, 2014

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 3, 2011

    PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021