BEUDAMED
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    ENDOSCOPIC FIBEROPTIC CABLE

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

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310219313·FG Diamond 390-014 football coarse 5/pack

    GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 13, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 27, 2015

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 25, 2011

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FTJ·March 28, 2008

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 8, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q 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.·October 18, 2017