BEUDAMED
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    IASSIST KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037626·Unitek(TM) Bicuspid Band General Purpose Narrow...

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138124776·GAIT BELT W/BUCKLE 2 X 36

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840967100012·Hinged Straight Lamina Spreader, Thin

    SURFIX KNEE OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AFFIRM DO DIODE LASER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    L9000 LIGHTSOUCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 31, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021