75717
|
Z-0928-2009
|
Terminated
|
LLZ
|
2008-11-21
|
GE Healthcare Integrated IT Solutions
|
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
|
75726
|
Z-0662-2009
|
Terminated
|
GCJ
|
2008-12-09
|
Ethicon Endo-Surgery Inc
|
Ethicon Endo-Surgery ENDOPATH¿ Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Code EPS08)
|
75472
|
Z-0890-2009
|
Terminated
|
JWH
|
2008-11-13
|
Stryker Howmedica Osteonics Corp.
|
Triathlon-Press-Fit Stem
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.
|
74662
|
Z-0575-2009
|
Terminated
|
NON
|
2008-08-08
|
Sterilmed Inc
|
Biopsy Forceps, Cold
Model #'s:
BAR000386
BAR000388
MIC1012
MIC1331
MIC1333
MIC1337
MIC1536
MIC1589
MIC1597
MIC1598 and
MIC1599
The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.
|
75698
|
Z-0868-2009
|
Terminated
|
HRX
|
2008-12-01
|
Stryker Endoscopy
|
Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802.
The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically.
Manufactured by Stryker Endoscopy Puerto Rico
|
70457
|
Z-0390-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile ST RECIPROCATOR BLADE, Catalog # 00505217300
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
70470
|
Z-0403-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile STER RPLCMNT BLADE/STRYKER RECIP, Catalog # 00505213500
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
73676
|
Z-0549-2009
|
Terminated
|
NLU
|
2008-08-08
|
Sterilmed Inc
|
Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.
|
70456
|
Z-0389-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog # 00507116600
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
76192
|
Z-0882-2009
|
Terminated
|
HTZ
|
2008-12-18
|
Biomet, Inc.
|
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485159. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
|
74664
|
Z-0577-2009
|
Terminated
|
HTO
|
2008-08-08
|
Sterilmed Inc
|
Reamers
Model #'s:
HAL5091-144 and
ZIMS5979-95-41
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
|
70432
|
Z-0372-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile REPEAT STERNOTOMY BLADE, Catalog # 00502317800
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
73698
|
Z-0568-2009
|
Terminated
|
GEI
|
2008-08-08
|
Sterilmed Inc
|
RF Arthroscopy Probe
Model #'s:
ARTA1325-01
ARTA1335-01
ARTA1345-01
ARTA1730-01
ARTA2630-01
ARTA3625-01
ARTA4330-01
ARTAS1335-01
ARTAS4630-01
ARTASC1335-01
ARTASC2530-01
ARTASC4250-01
ARTASC4830-01
ARTASC5000-01
ARTASC5500-01
ARTEIC4845-01
MIT225203
MIT225301
MIT225302
MIT225305
MIT225350
MIT225360
SMI7209681
SMI7209682
SMI7209683 and
STR278-510-500
These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue.
|
73693
|
Z-0565-2009
|
Terminated
|
NKX
|
2008-08-08
|
Sterilmed Inc
|
Phaco Tips
Model #'s:
ALC30RTS
ALC8065740806
ALC8065740809
ALC8065740837
ALC8065740839
ALC8065750852
ALC8065790020
ALC8065790022 and
ALLOPOR3020L
Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
|
70467
|
Z-0400-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog # 00505953200
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
70455
|
Z-0388-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD, Catalog # 00507157200, 00507155400, and 00507155500.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
70426
|
Z-0366-2009
|
Terminated
|
GET
|
2008-02-21
|
Linvatec Corp.
|
ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and 00507158200.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
|
73499
|
Z-0530-2009
|
Terminated
|
JHI
|
2008-08-18
|
Mainline Technology, Inc.
|
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
|
73700
|
Z-0570-2009
|
Terminated
|
NUJ
|
2008-08-08
|
Sterilmed Inc
|
Scissor Tips
Model #'s:
AESPO888
AESPO889
ENCES0102
MIC3112
MIC3122
MIC3142
MIC3152
SNO89-5100 and
SNO89-5300
Intended to be used with a resusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue.
|
73893
|
Z-0580-2009
|
Terminated
|
JIX
|
2008-09-12
|
Abbott Laboratories Inc.
|
ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04.
The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.
|