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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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+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • Electronic surgical sponge-counter
QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter
Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system
Cranial Guidance Software
Stryker Leibinger GmbH & Co. KG
6000-670-000
In Commercial Distribution

  • 07613327538298 ()
6000-670-000

  • Electromagnetic/optical surgical navigation device tracking system
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital
Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system
Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server
Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit
Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit
Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution

  • 00815962020306 ()


  • Transcutaneous electrical stimulation probe
Clinician Programmer Software
BIONESS INC.
H2W-SW01
In Commercial Distribution

  • 00815962020290 ()


  • Hand orthosis
TrueFit Software v5.4
Sonova AG
058-5178-054
In Commercial Distribution

  • 07613389644579 ()
058-5178-054

  • Audiometric/hearing device software
Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier
PROFESS(TM) SOFTWARE
Stryker Leibinger GmbH & Co. KG
6001-400-000
In Commercial Distribution

  • 07613327071948 ()
6001-400-000

  • Robotic surgical navigation system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-51    
In Commercial Distribution

  • 00812345024715 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-50    
In Commercial Distribution

  • 00812345024708 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system
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