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91256
|
Z-2051-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|
|
91653
|
Z-1963-2010
|
Terminated
|
MDM
|
2010-05-13
|
Stryker Spine
|
Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended for use in the thoraco-lumbar spine.
|
|
92555
|
Z-2072-2010
|
Terminated
|
MUJ
|
2010-06-23
|
TomoTherapy Incorporated
|
TomoTherapy Hi-Art System¿, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¿ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
|
|
92730
|
Z-2075-2010
|
Terminated
|
DWF
|
2010-06-18
|
Sorin Group USA, Inc.
|
Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
|
|
90688
|
Z-2216-2010
|
Terminated
|
LPH
|
2010-04-06
|
Zimmer Inc.
|
Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ.
Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
|
|
84710
|
Z-1802-2010
|
Terminated
|
FGE
|
2009-07-30
|
Medtronic CardioVascular
|
Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA.
Medical device system consisting of a balloon-expandable intraluminal stent premounted onto the balloon of an over the wire delivery catheter. The system as two radiopaque markers on the inner member and positioned to each side of the stent, to aid in the placement of the stent during fluoroscopy. The system is compatible with labeled guidewires. The device is provided sterile and pyrogenic. It is indicated for use in the palliation of malignant neoplasms in the biliary tree.
|
|
92626
|
Z-2080-2010
|
Terminated
|
JOH
|
2010-04-21
|
Cook, Inc.
|
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
|
|
92829
|
Z-2107-2010
|
Terminated
|
GGN
|
2010-07-08
|
International Technidyne Corporation
|
GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:
IVD. 15/pk. 06260061600.
Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125.
Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
|
|
94079
|
Z-2567-2010
|
Terminated
|
FMI
|
2010-08-30
|
Multi-Med, Inc.
|
Marquette Medical Huber Trap-A Safety Huber Needle
22ga x .75" Winged Administration Set w/Y Site
Model # MW223Y
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
|
|
90219
|
Z-2590-2010
|
Terminated
|
JJE
|
2010-02-25
|
Beckman Coulter Inc.
|
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software
version: 4.9.01
The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
|
|
93734
|
Z-2638-2010
|
Terminated
|
LFL
|
2010-07-29
|
Integra LifeSciences Corp.
|
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System
CUSANXT2: Latex Free, Rx only.
Integra LifeSciences (Ireland) Limited
County Offaly, Ireland
Distributed by Integra Lifesciences Corporation
311 Enterprise Drive
Plainsboro, NJ 08536.
|
|
93943
|
Z-2539-2010
|
Terminated
|
FMI
|
2010-08-30
|
Multi-Med, Inc.
|
All Med Medical 20ga x .75" RA Hub Needle
Model #M2075H
Reorder #55-2020
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
|
|
93307
|
Z-2596-2010
|
Terminated
|
GEI
|
2010-07-27
|
Hemostatix Medical Technologies LLC
|
MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK
The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
|
|
93832
|
Z-2599-2010
|
Terminated
|
LXH
|
2010-07-01
|
Biomet, Inc.
|
9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures.
|
|
93799
|
Z-2627-2010
|
Terminated
|
FPA
|
2010-08-12
|
Hospira Inc.
|
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 12640-01
|
|
93959
|
Z-2549-2010
|
Terminated
|
FMI
|
2010-08-30
|
Multi-Med, Inc.
|
All Med Medical 22ga x 1.50" RA Hub Needle
Model #M2215H
Reorder #55-2240
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
|
|
93803
|
Z-2631-2010
|
Terminated
|
FPA
|
2010-08-12
|
Hospira Inc.
|
Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V. Secure Lock and Non-DEHP, 59 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19680-28
|
|
88791
|
Z-2618-2010
|
Terminated
|
ITI
|
2010-02-01
|
Pride Mobility Products Corp
|
Jazzy Select with XLR Port Harness
|
|
93940
|
Z-2536-2010
|
Terminated
|
FMI
|
2010-08-30
|
Multi-Med, Inc.
|
All Med Medical 19ga x 1" RA Hub Needle
Model #M191H
Reorder #55-1930
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
|
|
94138
|
Z-2577-2010
|
Terminated
|
FMI
|
2010-08-30
|
Multi-Med, Inc.
|
ALLMED Huber Needles
22ga x 1" Straight Hub Needle - Bulk, Non-Sterile
Model # M221HS-NS Reorder # 55-2230
Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
|