BEUDAMED
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    SPI VARIO ANGLED ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Relief Pak 8 pack heating Unit

    FDA UDI
    KARIS Co.,Ltd·08809520550239·It is a device intended for medical purposes th...

    Relief Pak 8 pack heating Unit mobile

    FDA UDI
    KARIS Co.,Ltd·08809520550550·It is a device intended for medical purposes th...

    GEL FILLED MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP·Product code FTR·October 30, 1996

    SLIM E30 II CO2 LASER

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

    BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code FPA·June 2, 2011

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·August 12, 2008

    Torcon NB

    FDA UDI
    COOK INCORPORATED·00827002107960·Torcon NB, Advantage Catheter

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Torcon NB

    FDA UDI
    COOK INCORPORATED·00827002470859·Torcon NB Advantage Catheter

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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