BEUDAMED
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    ESKA JONAS SILICON-SILVER PENILE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    1077 EARTIP 6-9MM BLUE 100 PCS

    FDA UDI
    PATH medical GmbH·04260223145339·

    SURGITEK ULTRA-LO CUFF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HERPES IDENT. & TYPING TEST HITT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·May 2, 2014

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 15, 2012

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·September 10, 2010

    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 11, 2014

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015