BEUDAMED
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    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001529·artVeneer life upper anteriors, CM, BL1

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161392082·GRADIA® INTENSIVE COLOR SET 11 SHADES

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782022597·CC/ Shoulder SP-29 honey

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0015291·CC/ Shoulder SP-29 honey 15g

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470015291·GRADIA® INTENSIVE COLOR SET 11 SHADES

    FAC-4 - Duke Power Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet

    Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000504·Scanlan® VASCU-STATT® II single-use bulldog cla...

    LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GEIGER NEEDLE ADAPTER, MODEL 406

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970850·

    RAPIDLAB 1265

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD·Product code CHL·March 6, 2013

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 25, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·February 21, 2008

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016