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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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Athena GTX Device Management Suite (ADMS) Software - B3943900008000

Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor

WVSM Wireless Vital Signs Monitor - B3943900004000

WVSM Management Suite - PC
ATHENA GTX, INC.
PC Software
In Commercial Distribution

  • B3943900004000 ()
390-0004-00

  • Centralized patient monitor

EyeSuite Software - 07640132986105

No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system

Arthrex® - 00888867387928

BioOptico Spectral Mode Key Kit
ARTHREX, INC.
AR-3200-1026
In Commercial Distribution

  • 00888867387928 ()
AR-3200-1026

  • Medical image management system

EyeSuite Software - 07640132987256

No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system

Criticare - B438560DNUS0

Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNVP30

Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNP30

Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNVP30

Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical

BCI - 10610586036347

No Description
ICU MEDICAL, INC.
3304
In Commercial Distribution

  • 10610586036347 ()


  • Multiple vital physiological parameter monitoring system, clinical

Amimon - 00817157020825

No Description
AMIMON LTD
MD52 Rx - MDWL2_B3P1RX
In Commercial Distribution

  • 00817157020825 ()


  • Medical image management system

Amimon - 00817157020818

No Description
AMIMON LTD
MD52 Tx - MDWL2_B1P1TX
In Commercial Distribution

  • 00817157020818 ()


  • Medical image management system

Amimon - 00817157020771

No Description
AMIMON LTD
MD11 System - MDWL1_B1N1RX
In Commercial Distribution

  • 00817157020771 ()


  • Medical image management system

Amimon - 00817157020764

No Description
AMIMON LTD
MD11 System - MDWL1_C1N1TX
In Commercial Distribution

  • 00817157020764 ()


  • Medical image management system

Amimon - 00817157020757

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1RX
In Commercial Distribution

  • 00817157020757 ()


  • Medical image management system

Amimon - 00817157020740

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1TX
In Commercial Distribution

  • 00817157020740 ()


  • Medical image management system

Portable X-Ray System - 00817100020353

Portable X-Ray System-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR301
In Commercial Distribution

  • 00817100020353 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020124

SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR310
In Commercial Distribution

  • 00817100020124 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020117

SR-130 + DR Portable X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR300
In Commercial Distribution

  • 00817100020117 ()


  • Portable basic diagnostic x-ray system, digital
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