BEUDAMED
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    SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code MBB·September 16, 2013

    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·August 14, 2019

    SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·October 30, 2013

    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code KNW·May 2, 2019

    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code MAV·April 12, 2017

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code MAV·August 25, 2016

    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

    FDA Recall
    Terminated ·Medtronic Vascular·Product code MAV·February 6, 2014

    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MBV·November 15, 2012

    Viceroy Inflation Syringe, 60mL, without gauge.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·October 21, 2005

    IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    FDA Recall
    Terminated ·PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France·Product code MAV·October 6, 2014

    Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

    FDA Recall
    Terminated ·Abbott Vascular·Product code MAV·July 3, 2018

    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code MAV·June 7, 2017

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    FDA Recall
    Terminated ·Perouse Medical 135, Route Neuve Irigny France·Product code MAV·May 10, 2012

    Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22

    FDA Recall
    Terminated ·Deltec, Inc·Product code MDV·March 29, 2004

    Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005