BEUDAMED
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    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·April 1, 2015

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·August 12, 2015

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·September 14, 2016

    Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 12, 2014

    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·February 6, 2013

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·May 6, 2015

    An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·April 9, 2014

    (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Monaco RTP System. Radiation treatment planning.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 27, 2013

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·May 27, 2015

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·May 27, 2015

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·May 27, 2015

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·May 27, 2015

    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·October 16, 2019

    Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·October 16, 2019

    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 16, 2013