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    U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI

    Stablecut®

    FDA UDI
    SYNVASIVE TECHNOLOGY, INC.·00846795004508·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493384·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857530010·Replaceable Tip

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016050·ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 4...

    NIROYAL BILIARY PREMOUNTED STENT SYSTEM

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

    XIO RTP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 4, 2022

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 14, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·April 29, 2011

    PS TIBIAL INSERTS SZ 3, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 8, 2022

    KNEE IMPLANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 7, 2024

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 18, 2024

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2024

    LOGIC FEMORAL PS CEM RIGHT SZ 4

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 8, 2025

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 3, 2024

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 12, 2024

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    FDA Recall
    Terminated ·Innovative Magnetic Resonance Imaging Systems Inc.·Product code LNH·October 19, 2012