BEUDAMED
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    REPROCESSED ELECTROSURGICAL ELECTRODES

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

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441725·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033441749·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033441732·

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    FDA UDI
    FGX INTERNATIONAL INC.·00193033441718·

    EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1

    FDA 510(k)
    FDA Class 2 ·Neurology

    CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005

    METRX

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code LXH·March 20, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    UNKNOWN ZIMMER LPS FLEX ARTICULATING SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 12, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020