BEUDAMED
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    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576965·CoRoent Ant TLIF PEEK, 10x12x32mm 0°

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009649·BELLA STRONG 20-30 MM HG ARMSLEEVE DOT BAND SIZ...

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375388·Integra® Jarit® Potts-Smith Scissors, 7-1/2", S...

    Temp Fix

    FDA UDI
    Harvest Dental Products, LLC·D8701023201·Temp Fix Disc, 98 X 20mm, Shade B2

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776352868·Potts Smith Super Cut,

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0123200·Inserter, Tulips and Connectors

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO1023200·Trial, Offset Bi-Convex, 10 x 34mm, 10mm.

    Viceroy

    FDA UDI
    DIOMEDICAL CO.,LTD.·08800113904866·VICEROY Rod - 5.5 (D)5.5x(L)320mm

    POWERPRO BATTERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACCOLADE C FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 20, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 30, 2013

    ACCU-CHEK ® PERFORMA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·September 19, 2014

    INTELLIFILL IV ROBOT

    FDA Adverse Event
    Injury ·BAXA CORP·Product code NEP·May 19, 2011

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·June 25, 2021

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023