BEUDAMED
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    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

    FDA Enforcement
    Class II ·Terminated·Zeiss, Carl Inc·July 24, 2013

    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

    FDA Recall
    Terminated ·Zeiss, Carl Inc·Product code IBJ·May 28, 2013

    Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (7Fr); 1 - Fixed Volume Syringe - 3cc; 1 - CSR Wrap***Catalog Number: 660007000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OHR·December 22, 2010

    Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30"x30")***Catalog Number: 660005000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OHR·December 22, 2010

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·April 20, 2016

    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Enforcement
    Class II ·Terminated·Ormco/Sybronendo·April 9, 2014

    TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·February 26, 2020

    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·July 12, 2017

    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Enforcement
    Class II ·Terminated·Ormco/Sybronendo·April 9, 2014

    GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    FDA Enforcement
    Class II ·Terminated·Ossur North America Inc·November 27, 2013

    REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013

    REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 17, 2013