|
90648
|
Z-1486-2010
|
Terminated
|
BTO
|
2010-04-13
|
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
|
Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
|
|
90656
|
Z-1490-2010
|
Terminated
|
JOH
|
2010-04-13
|
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
|
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
|
|
90876
|
Z-1505-2010
|
Terminated
|
JOH
|
2010-04-13
|
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
|
Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
|
|
91603
|
Z-1762-2010
|
Terminated
|
MSD
|
2010-01-08
|
Angiodynamics, Inc.
|
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
|
|
86707
|
Z-1753-2010
|
Terminated
|
NOE
|
2009-10-29
|
DiaDexus, Inc
|
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
|
|
90514
|
Z-1742-2010
|
Terminated
|
KGC
|
2010-03-29
|
Argon Medical Devices, Inc
|
ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
|
|
90003
|
Z-2184-2010
|
Terminated
|
INK
|
2010-03-19
|
Stryker Medical Div. of Stryker Corporation
|
Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI.
|
|
92305
|
Z-2206-2010
|
Terminated
|
DZL
|
2010-03-17
|
Biomet Microfixation, Inc.
|
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM.
Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
|
|
92761
|
Z-2196-2010
|
Terminated
|
NMF
|
2010-06-23
|
Ascent Healthcare Solutions, Inc.
|
ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
|
|
92213
|
Z-2204-2010
|
Terminated
|
JWH
|
2010-04-20
|
Biomet, Inc.
|
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
|
|
92696
|
Z-2190-2010
|
Terminated
|
DXE
|
2010-07-01
|
Spectranetics Corporation
|
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
|
|
91000
|
Z-2211-2010
|
Terminated
|
MSX
|
2010-06-25
|
Ge Healthcare, Llc
|
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.
|
|
91913
|
Z-1846-2010
|
Terminated
|
JCT
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
|
|
91991
|
Z-1855-2010
|
Terminated
|
JCT
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
|
|
91982
|
Z-1849-2010
|
Terminated
|
JCT
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
|
|
92032
|
Z-1911-2010
|
Terminated
|
OCK
|
2010-04-27
|
Rochester Medical Corp
|
FemSoft Insert, Female Urethral Insert, Size 2 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72202 or 72202DT.
Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
|
|
80552
|
Z-1901-2010
|
Terminated
|
LCP
|
2009-01-22
|
Bio-Rad Laboratories Inc
|
VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.
Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.
|
|
91891
|
Z-1825-2010
|
Terminated
|
JCT
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
|
|
91739
|
Z-1906-2010
|
Terminated
|
OCK
|
2010-04-27
|
Rochester Medical Corp
|
FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only.
Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
|
|
92007
|
Z-1867-2010
|
Terminated
|
ESW
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
|