BEUDAMED
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    Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design

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

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169502222·INTERBODY 2151112 SMALL - 6 DEG 12MM

    Eagle Derma2 Nitrile Examination Gloves

    FDA UDI
    Eagle Protect Pbc·09421024254162·Derma2 Nitrile Examination Gloves, Blue, Powder...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704282962·LANGENBECK RETRACTOR 5/8"x1 1/2"

    ProLift Expandable Spacer System

    FDA UDI
    Life Spine, Inc.·00190837065621·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321511120·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311511120·

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1511120·Smooth Fixation Pin, ø3mm x 120mm

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020379·Posterior Stabilized Tibial Insert

    Trulink

    FDA UDI
    STATCORP MEDICAL·10841522128554·BP CUFF,TL VINYL,1T,INFANT,8-14CM,HP,5/BG

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 11, 2018

    RELIANCE SPINAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WHITTLESTONE EXPRESSER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ORGENICS LTD·Product code MZF·May 18, 2016

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ORGENICS LTD·Product code MZF·May 16, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    STANDARD INSERT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2011

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 21, 2019

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014