BEUDAMED
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    HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES

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

    SYNCHROMED ® II

    FDA UDI
    MEDTRONIC, INC.·00643169100831·PUMP 8637-20 SYNCHMED II 20ML PF

    SYNCHROMED® II

    FDA UDI
    MEDTRONIC, INC.·00643169630505·PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL

    SYNCHROMED ® II

    FDA UDI
    MEDTRONIC, INC.·00613994779229·PUMP 8637-20 SM2 20ML EMAN US JUN BATRY

    SYNCHROMED®II

    FDA UDI
    MEDTRONIC, INC.·00763000422608·PUMP 8637-20 SM II 20ML EMAN SYMBL GRC

    SYNCHROMED® II

    FDA UDI
    MEDTRONIC, INC.·00643169508149·PUMP 8637-20 SYNCHMED II 20ML POTTED FTS

    SynchroMed® II

    FDA UDI
    MEDTRONIC, INC.·00643169530119·PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR

    SYNCHROMED®II

    FDA UDI
    MEDTRONIC, INC.·00643169984219·PUMP 8637-20 SYNCHROMED II 20ML DLC US

    SYNCHROMED® II

    FDA UDI
    MEDTRONIC, INC.·00763000634094·PUMP 8637-20 SM II 20ML EMAN SYMBL

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·February 10, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTROPHOTOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·December 5, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·December 5, 2020

    MEDTRONIC SYNCHROMED MODEL #8637-20

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LKK·May 26, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code LKK·April 8, 2020

    INDURA CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·January 22, 2016

    Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·March 14, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 1, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 23, 2019