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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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Exercise test software
NIHON KOHDEN AMERICA, INC.
QP-156E
Not in Commercial Distribution

  • 00841983101298 ()
QP-156E

  • Electrocardiograph, professional, multichannel
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder
EncorePro 2, Software
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048348 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048331 ()
1099731

  • Medical equipment clinical data interfacing software
OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system
EncorePro 2, Software
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959043114 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959042957 ()
1099731

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.19
In Commercial Distribution

  • 00606959040434 ()
1099731

  • Medical equipment clinical data interfacing software
myQA iON software
IBA Dosimetry GmbH
MQ10-000
In Commercial Distribution

  • EIBAMQ100000 ()


  • Accelerator system quality assurance device
myQA Daily Software
IBA Dosimetry GmbH
DQ00000
In Commercial Distribution

  • EIBADQ000000 ()
DQ00-000

  • Accelerator system quality assurance device
EncorePro2 Software, web
Respironics, Inc.
EncorePro2 - 2
In Commercial Distribution

  • 00606959055001 ()
1099731

  • Medical equipment clinical data interfacing software
EncorePro2 Software (Web)
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959053786 ()
1099731

  • Medical equipment clinical data interfacing software
EncorePro 2, Software
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050778 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050761 ()
1099731

  • Medical equipment clinical data interfacing software
KeypointNET Software 2.40
NATUS MANUFACTURING LIMITED
9031S2308
In Commercial Distribution

  • 00382830050852 ()
9031S2308

  • Electromyograph
Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software
ENDEAVOR SOFTWARE V7
NATUS NEUROLOGY INCORPORATED
482-649300
In Commercial Distribution

  • 00382830037990 ()


  • Electromyograph
EMG Reader Software
NATUS NEUROLOGY INCORPORATED
828-069700
In Commercial Distribution

  • 00382830035002 ()


  • Electromyograph
Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 04250892980249 ()
36-SWR1134

  • Pulmonary function analysis system, adult
Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 04250892904153 ()
36-SWR1134

  • Diagnostic spirometer, professional
Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 04250892901633 ()
36-SWR1134

  • Pulmonary function analysis system, adult
Exercise test software
NIHON KOHDEN CORPORATION
QP-156E
Not in Commercial Distribution

  • 04931921113400 ()
QP-156E

  • Electrocardiograph, professional, multichannel
Digital video software
NIHON KOHDEN CORPORATION
QP-110AK
In Commercial Distribution

  • 04931921100769 ()
QP-110AK

  • Electroencephalograph
UPGRADE SOFTWARE PROGRAM
NIHON KOHDEN CORPORATION
QS-010BK
In Commercial Distribution

  • 04931921006429 ()


  • Evoked-potential graphic recording system
FLUOROSCOPY SOFTWARE 2.3
Stryker Leibinger GmbH & Co. KG
6004-650-000
In Commercial Distribution

  • 04546540505712 ()
6004-650-000

  • Robotic surgical navigation system application software
Quality Control Software
EIZO CORPORATION
Ver.5.2.x
In Commercial Distribution

  • 04995047067740 ()
RadiCS

  • Radiology workstation display quality assurance software
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