BEUDAMED
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    SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799006592·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052436·1.6mm Extended Twist Drill, 4mm STOP, Hex Shank

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 26, 2021

    Tandry Locking Plate System

    FDA UDI
    MICROWARE PRECISION CO., LTD.·04719873098026·2.4mm Locking Volar Distal Radius Plate, 4 Hole...

    AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·May 6, 2021

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 8, 2017

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 6, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·August 13, 2008

    OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025