BEUDAMED
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    ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER

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

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832021703·GLENOID ANTIROTATION PEGS

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014602271·Radiolucent Armboard

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862161154·

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    DuoFLEX® Coil Suite

    FDA UDI
    M R Instruments, Inc.·00857371006380·The 24cm Right Coil Assembly is a part of the D...

    DuoFLEX® Coil Suite

    FDA UDI
    M R Instruments, Inc.·00857371006373·The 24cm Left Coil Assembly is a part of the Du...

    CORTEK CYSTOSCOPE

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

    GSI 2000 MIDDLE EAR ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 12, 2013

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·February 18, 2011

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·EBI·Product code KWQ·February 14, 2008

    PRODIGY LG STAT SHT LT 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016

    145-DEG PE 42MM CONST HUM LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 8, 2025

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016