131839
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Z-1114-2015
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Terminated
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HSD
|
2014-11-24
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Arthrosurface, Inc.
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Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
|
132890
|
Z-1126-2015
|
Terminated
|
FRN
|
2015-01-16
|
CME America, LLC
|
BodyGuard 323 pump, models
100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS,
100-603XSA and 100-603XSAP
|
133315
|
Z-1125-2015
|
Terminated
|
DXH
|
2015-01-09
|
Alivecor SFO
|
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
|
133460
|
Z-1132-2015
|
Terminated
|
LPH
|
2014-12-17
|
|
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
|
133254
|
Z-1256-2015
|
Terminated
|
JKA
|
2015-01-22
|
Siemens Healthcare Diagnostics Inc
|
Siemens Healthcare Caps for capillary 100 uL , Package count 200
For use with blood collection Multicap glass and Multicap-S plastic capillaries
SMN: 10311053
Legacy Part number: 478601
|
133854
|
Z-1250-2015
|
Terminated
|
ILY
|
2014-12-17
|
Pivotal Health Solutions
|
Apollo (cold) Laser Desktop Control Units, Model AP2-DT.
The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
|
133255
|
Z-1257-2015
|
Terminated
|
JKA
|
2015-01-22
|
Siemens Healthcare Diagnostics Inc
|
Siemens Healthcare Caps for capillary 140/175 uL, Package count 100
For use with blood collection Multicap glass and Multicap-S plastic capillaries
SMN: 10311054
Legacy Part number: 478605
|
133929
|
Z-1246-2015
|
Terminated
|
MBB
|
2015-02-11
|
DePuy Orthopaedics, Inc.
|
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
|
132741
|
Z-1278-2015
|
Terminated
|
KXG
|
2014-12-22
|
Puritan Medical Products Co., LLC
|
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT.
Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
|
134471
|
Z-1279-2015
|
Terminated
|
KPS
|
2015-03-05
|
GE Healthcare
|
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations.
Product Usage: The intended use of the system is 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.
|
134485
|
Z-1359-2015
|
Terminated
|
JAK
|
2015-02-05
|
Philips Medical Systems (Cleveland) Inc
|
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
|
131577
|
Z-1293-2015
|
Terminated
|
CGL
|
2014-10-29
|
Radiometer America Inc
|
Crea A and B membranes, packaged 4 per box
Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
|
134031
|
Z-1309-2015
|
Terminated
|
HQL
|
2015-02-13
|
Aaren Scientific, Incorporated
|
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0.
The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
|
123221
|
Z-1292-2015
|
Terminated
|
FKX
|
2013-10-16
|
Baxter Healthcare Corp.
|
The HomeChoice Pro APD System is a peritoneal dialysis system.
The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
|
134088
|
Z-1399-2015
|
Terminated
|
JGS
|
2015-02-11
|
Siemens Healthcare Diagnostics, Inc.
|
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD.
The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
|
138981
|
Z-2627-2015
|
Terminated
|
LRO
|
2015-07-10
|
Customed, Inc Calle Igualdad Final # 7
|
SURGICAL PACK 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
.
|
138952
|
Z-2604-2015
|
Terminated
|
OHD
|
2015-07-10
|
Customed, Inc Calle Igualdad Final # 7
|
O.B. PACK 4/CS REV.
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
.
|
139083
|
Z-2700-2015
|
Terminated
|
OJH
|
2015-07-10
|
Customed, Inc Calle Igualdad Final # 7
|
ORTHO-IMPLANT SURGICAL PACK,
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
.
|
138872
|
Z-2564-2015
|
Terminated
|
OHD
|
2015-07-10
|
Customed, Inc Calle Igualdad Final # 7
|
PERY GYN PACK CUSTOMED 10/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
.
|
139473
|
Z-2539-2015
|
Terminated
|
KWT
|
2015-08-14
|
Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy
|
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445;
SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
|