67942
|
Z-1124-2008
|
Terminated
|
FGE
|
2008-01-18
|
|
ev3 IntraStent LD DoubleStrut
Large Diameter Biliary Stent, Model Number: S15-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000.
ev3 IntraStent LD DoubleStrut
Large Diameter Peripheral Stent, Model Number: S15-16,
Catalog Number: 90-1504-000 (not approved within USA).
|
67232
|
Z-0994-2008
|
Terminated
|
HBE
|
2008-01-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-123.
|
66509
|
Z-1074-2008
|
Terminated
|
BZD
|
2007-10-15
|
Respironics, Inc.
|
Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66516
|
Z-1081-2008
|
Terminated
|
BZD
|
2007-10-15
|
Respironics, Inc.
|
RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66517
|
Z-1082-2008
|
Terminated
|
CBK
|
2007-10-15
|
Respironics, Inc.
|
RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66507
|
Z-1072-2008
|
Terminated
|
BZD
|
2007-10-15
|
Respironics, Inc.
|
RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
67238
|
Z-1000-2008
|
Terminated
|
HBE
|
2008-01-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-71-223.
|
67239
|
Z-1001-2008
|
Terminated
|
HBE
|
2008-01-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-107-30.
|
66522
|
Z-1085-2008
|
Terminated
|
CBK
|
2007-10-15
|
Respironics, Inc.
|
Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x ¿ 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66494
|
Z-1060-2008
|
Terminated
|
CBK
|
2007-10-15
|
Respironics, Inc.
|
Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66523
|
Z-1086-2008
|
Terminated
|
NPF
|
2007-10-15
|
Respironics, Inc.
|
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
66504
|
Z-1069-2008
|
Terminated
|
BZD
|
2007-10-15
|
Respironics, Inc.
|
Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
|
67249
|
Z-1011-2008
|
Terminated
|
HBE
|
2008-01-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-150.
|
69114
|
Z-1457-2008
|
Terminated
|
GCY
|
2008-01-31
|
Zimmer Inc.
|
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio
|
67039
|
Z-0585-2008
|
Terminated
|
GEX
|
2007-12-18
|
Lumenis, Inc.
|
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
|
69106
|
Z-1449-2008
|
Terminated
|
GCY
|
2008-01-31
|
Zimmer Inc.
|
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Cntrl. Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107 cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio
|
67194
|
Z-0912-2008
|
Terminated
|
EZN
|
2007-11-30
|
Boston Scientific Corporation
|
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760
|
67211
|
Z-1106-2008
|
Terminated
|
JDZ
|
2008-01-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
|
67280
|
Z-1038-2008
|
Terminated
|
LLZ
|
2007-12-21
|
Siemens Medical Solutions USA, Inc
|
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
|
67218
|
Z-0915-2008
|
Terminated
|
FMF
|
2008-01-07
|
Becton Dickinson & Company
|
BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.
|