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No Description
SCC SOFT COMPUTER
4.1.17.241
In Commercial Distribution
- 00810055819249 ()
- Clinical laboratory information system application software
No Description
SCC SOFT COMPUTER
4.1.17.241
In Commercial Distribution
- 00810055819232 ()
- Clinical laboratory information system application software
No Description
SCC SOFT COMPUTER
4.1.17.30
In Commercial Distribution
- 00810055819041 ()
- Clinical laboratory information system application software
No Description
SCC SOFT COMPUTER
1.0.1.9
In Commercial Distribution
- 00810142372886 ()
- Clinical laboratory information system application software
No Description
SCC SOFT COMPUTER
4.2.0.11
In Commercial Distribution
- 00810142372961 ()
- Clinical laboratory information system application software
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution
- 00851458005143 ()
NGDS-ASY-0004
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution
- B885MAML2US0 ()
- X-ray image interpretive software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution
- B885MAML0 ()
MAML
- X-ray image interpretive software
Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution
- 00812282020160 ()
903001-003
- Fully-implantable middle ear implant system
NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution
- 60889971067708 ()
1067701
- Computed radiography digital imaging scanner
NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution
- 60889971067685 ()
1067685
- Computed radiography digital imaging scanner
CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution
- 00618874116040 ()
- Electronic epidural space locator control unit
CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution
- 00618874116033 ()
- Electronic epidural space locator control unit
BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution
- 00382904901899 ()
- Height: 33.2 Centimeter
- Width: 55 Centimeter
- Length: 59.2 Centimeter
490189
- Cell morphology analyser IVD, manual
Adapter Cable
ST. JUDE MEDICAL, INC.
12607
In Commercial Distribution
- 05414734050241 ()
12607
- Electrical-only medical device connection cable, reusable
Workstation
ST. JUDE MEDICAL, INC.
100026148
In Commercial Distribution
- 05414734031035 ()
100026148
- Cardiac mapping system
EP-TRACER 70 included in the portable system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS02
In Commercial Distribution
- 04260441455425 ()
- Cardiac electrophysiology analysis system
EP-TRACER 38 included in the portable system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS01
In Commercial Distribution
- 04260441455418 ()
- Cardiac electrophysiology analysis system
EP-TRACER 70 included in the stationary system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
32SYS02
In Commercial Distribution
- 04260441455326 ()
- Cardiac electrophysiology analysis system
EP-TRACER 102 included in the cart system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS03
In Commercial Distribution
- 04260441452639 ()
- Cardiac electrophysiology analysis system
EP-TRACER 70 included in the cart system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS02
In Commercial Distribution
- 04260441452622 ()
- Cardiac electrophysiology analysis system
EP-TRACER 38 included in the cart system setup.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS01
In Commercial Distribution
- 04260441452615 ()
- Cardiac electrophysiology analysis system
No Description
CardioTek B.V.
08ACC01
In Commercial Distribution
- 04260441450574 ()
- Cardiac electrophysiology analysis system
No Description
CardioTek B.V.
03UBC02
In Commercial Distribution
- 04260441450482 ()
- Cardiac electrophysiology analysis system
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking system
IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
Centerline Biomedical, Inc.
T02111
In Commercial Distribution
- 10843152103024 ()
- 00843152103027 ()
T02111
- Electromagnetic surgical navigation device tracking system
IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution
- 10843152103000 ()
- 00843152103003 ()
TP-1
- Electromagnetic surgical navigation device tracking system
Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution
- 10843152102058 ()
- 00843152102051 ()
H01035
- Electromagnetic surgical navigation device tracking system
Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
Centerline Biomedical, Inc.
ATW-2
In Commercial Distribution
- 10843152102034 ()
- 00843152102037 ()
ATW-2
- Cardiac/peripheral vascular guidewire, single-use
IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
Centerline Biomedical, Inc.
SSH-1
In Commercial Distribution
- 10843152102010 ()
- 00843152102013 ()
SSH-1
- Cardiac/peripheral vascular guidewire, single-use
IOPS™ Catheter Reverse Curve 1
Centerline Biomedical, Inc.
RCC-1
In Commercial Distribution
- 10843152101037 ()
- 00843152101030 ()
RCC-1
- Vascular guide-catheter, single-use
IOPS™ Catheter Simple Curve 1
Centerline Biomedical, Inc.
SCC-1
In Commercial Distribution
- 10843152101020 ()
- 00843152101023 ()
SCC-1
- Vascular guide-catheter, single-use
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution
- 00843152100002 ()
MC-1
- Electromagnetic surgical navigation device tracking system
ELECTRODE 9670590 5BX LOCALISA
MEDTRONIC, INC.
9670590
In Commercial Distribution
- 20643169006878 ()
- 00643169006874 ()
- Cardiac mapping system reference patch
No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004697 ()
H700469
- Cardiac mapping system
Connect
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004680 ()
H700468
- Cardiac mapping system
No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004604 ()
H700460
- Cardiac mapping system
Magnetic Transmitter Assembly
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004314 ()
H700431
- Cardiac mapping system
No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
- 05415067004307 ()
H700430
- Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H700386
In Commercial Distribution
- 05415067003867 ()
H700386
- Cardiac mapping system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution
- 05415067003560 ()
100043247
- Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
100041650
In Commercial Distribution
- 05415067003553 ()
100041650
- Cardiac catheterization monitoring system
No Description
ST. JUDE MEDICAL, INC.
09-0080-0000
In Commercial Distribution
- 05415067003461 ()
09-0080-0000
- Cardiac catheterization monitoring system
56 Channel SCU
ST. JUDE MEDICAL, INC.
100019209
In Commercial Distribution
- 05415067003126 ()
100019209
- Cardiac catheterization monitoring system
120 Channel SCU
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution
- 05415067003119 ()
09-1463-0120
- Cardiac catheterization monitoring system
DWS Kit
ST. JUDE MEDICAL, INC.
Velocity System
In Commercial Distribution
- 05415067003041 ()
100027825
- Electrical-only medical device connection cable, reusable
Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution
- 05415067003027 ()
100037184
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution
- 05415067002952 ()
H700295
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution
- 05415067002938 ()
H700293
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution
- 05415067002921 ()
H700292
- Cardiac mapping system application software