BEUDAMED
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    TECO DIAGNOSTICS SALIVA ALCOHOL TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481118326·LOCATOR R-Tx Abutment For 4.25mm Premium Implan...

    TALOS®-T

    FDA UDI
    SpineArt SA·07640332471586·TALOS-T (HA) LORDOTIC HA PEEK IBFD 6° L28 W10...

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321112060·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311112060·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

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

    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 18, 2016

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 19, 2016

    PROMUS ELEMENT¿ PLUS

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

    2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/6 HOLES/LEFT

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HRS·September 23, 2014

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·May 26, 2011

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016