|
68171
|
Z-1170-2008
|
Terminated
|
MEH
|
2008-01-21
|
Stryker Howmedica Osteonics Corp.
|
Trident Hemispherical Cluster;
42mm - 74 mm
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
|
|
68034
|
Z-1180-2008
|
Terminated
|
NAY
|
2007-12-27
|
Intuitive Surgical, Inc.
|
da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
|
|
68207
|
Z-1177-2008
|
Terminated
|
DTS
|
2008-01-24
|
California Medical Laboratories Inc
|
CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
|
|
68363
|
Z-1173-2008
|
Terminated
|
MEH
|
2008-01-21
|
Stryker Howmedica Osteonics Corp.
|
Trident PSL Acetabular Shells; Trident PSL HA Solid Back,
40 mm to 73 mm, hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
|
|
66383
|
Z-1157-2008
|
Terminated
|
LSE
|
2007-11-13
|
Bio-Rad Laboratories
|
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).
|
|
69063
|
Z-1473-2008
|
Terminated
|
CAW
|
2008-03-04
|
Medline Industries Inc
|
Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
|
|
68389
|
Z-1479-2008
|
Terminated
|
NKB
|
2008-02-13
|
Abbott Spine
|
Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only;
The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
|
|
67148
|
Z-2032-2008
|
Terminated
|
GKZ
|
2007-05-04
|
Beckman Coulter Inc
|
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 10 User Network, Automated differential cell counter; Part Number 774179; Beckman Coulter; Miami, FL 33196.
|
|
70502
|
Z-1781-2008
|
Terminated
|
NSA
|
2008-04-30
|
Philips Medical Systems
|
Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
|
|
67136
|
Z-2020-2008
|
Terminated
|
GKZ
|
2007-05-04
|
Beckman Coulter Inc
|
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 3 User Pack, Automated differential cell counter; Part Number 722397; Beckman Coulter; Miami, FL 33196.
|
|
64326
|
Z-0580-2008
|
Terminated
|
MMI
|
2007-06-07
|
Siemens Medical Solutions Diagnostics
|
ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
|
|
75975
|
Z-0872-2009
|
Terminated
|
CBK
|
2008-12-19
|
MAQUET Inc.
|
SERVO Ventilator 300A (SV300A);
Maquet Critical Care Ab, Solna, Sweden.
The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.
|
|
75764
|
Z-0798-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # F90732.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
77599
|
Z-0974-2009
|
Terminated
|
LYC
|
2009-01-22
|
Zimmer Inc.
|
Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003.
Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.
|
|
75656
|
Z-0752-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF3110-61.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
75668
|
Z-0764-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4115-6121Z.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
75659
|
Z-0755-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF3115-6121Z.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
75583
|
Z-0681-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # CF070-61.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
75690
|
Z-0785-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # SNDF1110-6131Z.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|
|
75677
|
Z-0773-2009
|
Terminated
|
CAI
|
2008-08-01
|
King Systems Corp.
|
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DFY170-6121.
This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
|