77820
|
Z-1120-2009
|
Terminated
|
KPS
|
2008-06-02
|
GE Medical Systems, LLC
|
GE Healthcare, Hawkeye¿ for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS.
The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
|
79673
|
Z-1154-2009
|
Terminated
|
FTD
|
2009-02-23
|
MAQUET Inc.
|
Alm Prismatic Surgical Light 5004 SF;
Maquet SA.
ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
|
77501
|
Z-1060-2009
|
Terminated
|
KNS
|
2008-06-05
|
Medtronic Neuromodulation
|
PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System.
PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico.
Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3.
|
74917
|
Z-1017-2009
|
Terminated
|
MNI
|
2008-10-31
|
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
|
Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
|
74692
|
Z-1027-2009
|
Terminated
|
KIJ
|
2008-10-10
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207.
The product is a linear cutting device used for cutting bone and bone related tissue including the sternum.
|
77508
|
Z-1011-2009
|
Terminated
|
LQR
|
2009-01-08
|
Boston Scientific Corp
|
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513.
The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
|
77537
|
Z-1159-2009
|
Terminated
|
LRS
|
2009-01-14
|
Tri-State Hospital Supply Corporation
|
Tri-State Centurion PICC Line Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CVI2370.
|
79654
|
Z-1142-2009
|
Terminated
|
JXG
|
2009-02-12
|
Medtronic Neurosurgery
|
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
|
79646
|
Z-1134-2009
|
Terminated
|
JXG
|
2009-02-12
|
Medtronic Neurosurgery
|
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
|
77540
|
Z-1164-2009
|
Terminated
|
MCY
|
2009-01-14
|
Tri-State Hospital Supply Corporation
|
Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder DT4825.
|
79642
|
Z-1132-2009
|
Terminated
|
JXG
|
2009-02-12
|
Medtronic Neurosurgery
|
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
|
79659
|
Z-1147-2009
|
Terminated
|
JXG
|
2009-02-12
|
Medtronic Neurosurgery
|
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
|
79645
|
Z-1133-2009
|
Terminated
|
JXG
|
2009-02-12
|
Medtronic Neurosurgery
|
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
|
79361
|
Z-1122-2009
|
Terminated
|
FSY
|
2009-02-27
|
Trumpf Medical Systems, Inc.
|
ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
|
77614
|
Z-1052-2009
|
Terminated
|
HWE
|
2009-01-27
|
Stryker Instruments Div. of Stryker Corporation
|
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI.
Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.
|
77408
|
Z-1043-2009
|
Terminated
|
LRF
|
2009-01-13
|
Lexamed
|
BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100
Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.
|
77460
|
Z-1037-2009
|
Terminated
|
FRN
|
2009-01-23
|
Baxter Healthcare Corp. Rt.
|
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, 2M9161, DNM8151, DNM9161, BRM8151, BRM8151T, BRM8151RT, PNM8151, PNM8151T, PNM8151RT, CNM8151, FKM8151, GNM8151, HNM8151, TRM8151 and WNM8151.
Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
|
73220
|
Z-1032-2009
|
Terminated
|
HTW
|
2008-07-30
|
Intelifuse Inc
|
InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom
Intended Use: Creating of holes for implant placement.
|
79162
|
Z-1075-2009
|
Terminated
|
KOD
|
2009-01-14
|
Rochester Medical Corp
|
Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308
Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976.
Intended for use for bladder management including urine drainage, collection and measurement.
|
34165
|
Z-1319-04
|
Terminated
|
JSO
|
2004-07-02
|
Becton Dickinson & Co.
|
Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
|