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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Rayvolve - 03770018071060

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : VM + Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071060 ()


  • X-ray image interpretive software

Rayvolve - 03770018071022

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
AZMED
2
In Commercial Distribution

  • 03770018071022 ()


  • X-ray image interpretive software

Rayvolve - 03770018071015

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Full Cloud)
AZMED
2
In Commercial Distribution

  • 03770018071015 ()


  • X-ray image interpretive software

Rayvolve - 03770018071008

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)
AZMED
2
In Commercial Distribution

  • 03770018071008 ()


  • X-ray image interpretive software

TechCare Trauma - 03770024774047

No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software

icobrain aria - B621ICOBRAINARIA1X1Y0

icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
icometrix NV
1.1
In Commercial Distribution

  • B621ICOBRAINARIA1X1Y0 ()


  • Radiology DICOM image processing application software

Critical Care Suite - 00195278789365

Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software

CLAB II Plus Amplifier - 00840682119634

ASSY CLABII PLUS64 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
64 Channel
Not in Commercial Distribution

  • 00840682119634 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CLAB II Plus Amplifier - 00840682119603

ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
128 Channel
In Commercial Distribution

  • 00840682119603 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Pathfinder - 10841522125645

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522125645 ()
040-1726-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software

Sentinel - 10841522123269

SENTINEL 10.0.1 STANDALONE WORKSTAT LICENCE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123269 ()
040-1702-00

  • Cardiology information system application software

Sentinel - 10841522123252

SENTINEL 10.0.1 OFFLINE/NETWORK WORKSTAT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123252 ()
040-1705-00

  • Cardiology information system application software

Sentinel - 10841522123245

SENTINEL 10.0.1 NETWORK WORKSTATION LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123245 ()
040-1703-00

  • Cardiology information system application software

Pathfinder - 10841522124563

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522124563 ()
040-1726-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

Sentinel - 10841522123238

SENTINEL 10.0.1 ADD. NETWORK WORKSTAT LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123238 ()
040-1704-00

  • Cardiology information system application software

SENTINEL - 10841522123221

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software

CNAP® Monitor 500 HD - 09120073933027

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073933027 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932990

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932990 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932266

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932266 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932242

Main Unit; including Quick Guide
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932242 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Endowrist SP - 00886874122228

CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope

CareLink Encore™ - 00643169369030

PROGRAMMER 29901 CARELINK ENCORE US
MEDTRONIC, INC.
29901
Not in Commercial Distribution

  • 00643169369030 ()


  • Cardiac pulse generator programmer

NA - 00681490207256

SFTWR 9766A 3MM CUT BURR 70MM 5/BX
MEDTRONIC, INC.
9766A
Not in Commercial Distribution

  • 00681490207256 ()


  • Cardiac pulse generator programmer

WiSE CRT System - 00859244007296

Programmer
EBR Systems, Inc.
5100
In Commercial Distribution

  • 00859244007296 ()


  • Cardiac pulse generator programmer

NA - 00721902546655

ECG PLUG 148743-1 US
MEDTRONIC, INC.
148743-1
In Commercial Distribution

  • 00721902546655 ()


  • Cardiac pulse generator programmer

CareLink Encore™ - 00643169763548

PRGM 29901A ENCORE US EIFU
MEDTRONIC, INC.
29901A
In Commercial Distribution

  • 00643169763548 ()


  • Cardiac pulse generator programmer

SJM™ - 05414734501668

Telemetry Wand
ST. JUDE MEDICAL, INC.
3630
In Commercial Distribution

  • 05414734501668 ()
3630

  • Cardiac pulse generator programmer

Medtronic CareLink® Programmer - 00721902824692

PRGM 2090AA4 PORTABLECRM
MEDTRONIC, INC.
2090AA4
Not in Commercial Distribution

  • 00721902824692 ()


  • Cardiac pulse generator programmer

NA - 00721902710353

CABLE R2067L RFHEAD 14FT REFURB
MEDTRONIC, INC.
R2067L
In Commercial Distribution

  • 00721902710353 ()

  • Length: 14.0 Feet


  • Cardiac pulse generator programmer

NA - 00721902710346

CABLE R2067 RF HEAD 9FT WRLDW REFURB
MEDTRONIC, INC.
R2067
In Commercial Distribution

  • 00721902710346 ()

  • Length: 9.0 Feet


  • Cardiac pulse generator programmer

NA - 00721902046940

SFTWR 9767 HEAD PRGMG RF TLMY SYS A/B
MEDTRONIC, INC.
9767
In Commercial Distribution

  • 00721902046940 ()


  • Cardiac pulse generator programmer

Hand adapter TOF3D - 04255629200430

No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
5750100
In Commercial Distribution

5750100

  • Sensor holder, reusable

NA - 04546540245038

UNIVERSAL TRACKER
Stryker Leibinger GmbH & Co. KG
6000-005-000
In Commercial Distribution

  • 04546540245038 ()
6000-005-000

  • Sensor holder, reusable

FUKUDA DENSHI - 04538612913792

No Description
FUKUDA DENSHI CO.,LTD.
FSD-8GA
In Commercial Distribution

  • 04538612913792 ()


  • Data storage card

FUKUDA DENSHI - 04538612913785

No Description
FUKUDA DENSHI CO.,LTD.
SD-16G
In Commercial Distribution

  • 04538612913785 ()


  • Data storage card

FUKUDA DENSHI - 04538612913778

No Description
FUKUDA DENSHI CO.,LTD.
FCS-64G
In Commercial Distribution

  • 04538612913778 ()


  • Data storage card

FUKUDA DENSHI - 04538612911231

No Description
FUKUDA DENSHI CO.,LTD.
FCF-16GA
In Commercial Distribution

  • 04538612911231 ()


  • Data storage card

FUKUDA DENSHI - 04538612911224

No Description
FUKUDA DENSHI CO.,LTD.
FCF-1000
In Commercial Distribution

  • 04538612911224 ()


  • Data storage card

FUKUDA DENSHI - 04538612911217

No Description
FUKUDA DENSHI CO.,LTD.
FCF-128
In Commercial Distribution

  • 04538612911217 ()


  • Data storage card
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