BEUDAMED
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    ADVANTA SUPER SOFT GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE

    FDA UDI
    Nuvasive, Inc.·00195377061379·PULSE Camera

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005041·HC 25 lb Pwd Clear

    Nobel

    FDA UDI
    Preat Corporation·00842092101070·NobelBiocare™ Tri-Lobe-compatible RP (4.3mm) Cl...

    PediFlex

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132133392·PEDIFLEX RT LID

    PenEvac1

    FDA UDI
    I.C. MEDICAL, INC.·00817688024125·PenEvac1®-NB, No Blade, 10 Foot Tube, Universal...

    ORHTO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·March 1, 2000

    CAPTURE™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780244233·CAPTURE™ High Torque Screw System The cannulate...

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209420482·FlowLogic Assert Shaping File 13/.02, 21mm

    Capture High Torque Cannulated Screw System

    FDA UDI
    Smith & Nephew, Inc.·00885556822890·CANNULATED TORX DRIVER. T40

    PHILOS II DR

    FDA Adverse Event
    Other ·BIOTRONIK GMBH AND CO.·Product code DXY·April 6, 2006

    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 31, 2011

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 14, 2008

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013