BEUDAMED
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    Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HJB·November 14, 2011

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code HPT·August 17, 2012

    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·July 10, 2013

    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·July 10, 2013

    DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile

    FDA Enforcement
    Class II ·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    FDA Enforcement
    Class II ·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020

    Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·May 23, 2013

    Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·May 23, 2013

    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 10, 2011

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    FDA Recall
    Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

    DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile

    FDA Recall
    Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

    The Maestor System 225-312, Profile Abutment for Cement, 5mm

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005

    BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007

    The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005

    BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007

    Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·April 18, 2007

    BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007

    BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·December 28, 2005

    BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007