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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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Holter Web Server Software
Lifesignals, Inc.
UA2251-W
In Commercial Distribution

  • B353UA2251W1 ()


  • Network server
Holter Central Server Software
Lifesignals, Inc.
UA2251-S
In Commercial Distribution

  • B353UA2251S1 ()


  • Network server
Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device
Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use
CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software
VERSATILE HIP 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6007-616-000
In Commercial Distribution

  • 07613327004250 ()
6007-616-000

  • Robotic surgical navigation system application software
GEMS Mobile ECG software
CardioComm Solutions, Inc
GM
In Commercial Distribution

  • 00812324000297 ()
GM

  • Electrocardiograph, home-use
FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software
SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software
vW CoFactor Opti8 Software
CHRONO-LOG CORP
vW CoFactor Opti8 Software
In Commercial Distribution

  • 00811476011670 ()


  • Platelet aggregation analyser IVD
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