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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No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MultiCal software
In Commercial Distribution

  • EPTWS0700080 ()
S070008

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
WedgeAngle Software
In Commercial Distribution

  • EPTWS0700070 ()
S070007

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
NOMEX software
In Commercial Distribution

  • EPTWS0300080 ()
S030008

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCanSet software
In Commercial Distribution

  • EPTWS0200120 ()
S020012

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200110 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200080 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic
BD FACSDiva™ Software
Becton, Dickinson And Company
659528
In Commercial Distribution

  • 00382906595287 ()
659528

  • Laboratory instrument/analyser application software IVD
BD FACSDiva™ Software
BECTON, DICKINSON AND COMPANY
659523
Not in Commercial Distribution

  • 00382906595232 ()
659523

  • Laboratory instrument/analyser application software IVD
Akunah Reflect Planning Software
AKUNAH PTY LTD
REFLECT
In Commercial Distribution

  • 09309002093005 ()


  • Orthopaedic/craniofacial implantation planning software
ARVIS Surgical Planning Software
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-27300
In Commercial Distribution

  • 09309001071011 ()


  • Orthopaedic/craniofacial implantation planning software
Simulset Version 3.1 Software
BECTON, DICKINSON AND COMPANY
343116
Not in Commercial Distribution

  • 00382903431168 ()
343116

  • Laboratory instrument/analyser application software IVD
FACSComp Version 4.0 Software
BECTON, DICKINSON AND COMPANY
343115
Not in Commercial Distribution

  • 00382903431151 ()
343115

  • Laboratory instrument/analyser application software IVD
Natus Elite Software - Viking
NATUS NEUROLOGY INCORPORATED
033416
In Commercial Distribution

  • 00382830061957 ()


  • Electromyograph
Natus Elite Software - Synergy
NATUS NEUROLOGY INCORPORATED
033415
In Commercial Distribution

  • 00382830061940 ()


  • Electromyograph
Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


  • Robotic surgical navigation system
MAXFRAME(TM) 2.0 SOFTWARE
Synthes GmbH
03.312.002
In Commercial Distribution

  • 07612334226563 ()
  • 10886982308641 ()
03312002

  • External orthopaedic fixation frame calculation software
X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software
Software Package, AS 2.3
Omni Life Science, Inc.
NS-27111
In Commercial Distribution

  • 00841690194422 ()
NS-27111

  • Robotic surgical navigation system application software
MAXFRAME AUTOSTRUT (TM) SOFTWARE
Synthes GmbH
03.312.003
In Commercial Distribution

  • 10886982346896 ()
03312003

  • External orthopaedic fixation frame calculation software
MAXFRAME AUTOSTRUT(TM) SOFTWARE
SYNTHES (U.S.A.) LP
1110005-01
In Commercial Distribution

  • 10886982340832 ()
111000501

  • External orthopaedic fixation frame calculation software
syngo Dynamics VA40 Software
Siemens Healthcare GmbH
10745960
In Commercial Distribution

  • 04056869253244 ()


  • Radiological PACS software
Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software
Care Orchestrator Software, Netherlands
Respironics, Inc.
1.14
In Commercial Distribution

  • 00606959052239 ()
1136535

  • Medical equipment clinical data interfacing software
Somnolyzer Software Service 24x7
Respironics, Inc.
Somnolyzer Software Service 24x7 - 2
In Commercial Distribution

  • 00606959006164 ()
1084709

  • Polysomnography analyser
Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
95430
In Commercial Distribution

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set
Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set
DirectView Software Version 2.4
Respironics, Inc.
DirectView PC Software Application, Web - 2
In Commercial Distribution

  • 00606959028630 ()
1063558

  • Medical equipment clinical data interfacing software
Software, OmniLab Direct, Web
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959038769 ()
1113127

  • Ventilator IMV controller
Software, Sleepware G3 (Multi-Lingual)
Respironics, Inc.
Sleepware G3 Software, Multi-Lingual - 3
In Commercial Distribution

  • 00606959045262 ()
1082463

  • Polysomnography analyser
Software, Sleepware G3 (EN)
Respironics, Inc.
Sleepware G3 Software, English - 3
In Commercial Distribution

  • 00606959045255 ()
1082462

  • Polysomnography analyser
OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system
HL7 Forwarding Service Software
Respironics, Inc.
Software, HL7 Forwarding Service - 3
In Commercial Distribution

  • 00606959039049 ()
1104880

  • Clinical laboratory information system
Sleepware G3 Software, Web
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959039001 ()
1115720

  • Polysomnography analyser
Charger Software Upgrade Kit
STRYKER CORPORATION
0408655200
In Commercial Distribution

  • 04546540591630 ()
0408655200

  • Surgical helmet system
ORTHOMAP¿ 3D 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6005-660-000
In Commercial Distribution

  • 04546540651600 ()
6005-660-000

  • Robotic surgical navigation system application software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52275
Not in Commercial Distribution

  • 09008737522759 ()


  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38208
In Commercial Distribution

  • 09008737382087 ()


  • Audiometric/hearing device software
Fitting and Configuring Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36363
In Commercial Distribution

  • 09008737363635 ()


  • Audiometric/hearing device software
TRUST Dental CAD Software
Rgorithm Korea
V1.0
In Commercial Distribution

  • 08809965590005 ()


  • CAD/CAM software
Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software
Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000100683 ()


  • Radiology picture archiving and communication system workstation
Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
2.0
In Commercial Distribution

  • 00842000100669 ()


  • Radiology picture archiving and communication system workstation
SOFTWARE, AUTO NERV, MEB-9400
NIHON KOHDEN AMERICA, INC.
QP-948BK
In Commercial Distribution

  • 00841983101335 ()
QP-948BK

  • Evoked-potential graphic recording system
SOFTWARE, SINGLE FIBER, MEB-9400
NIHON KOHDEN AMERICA, INC.
QP-947BK
In Commercial Distribution

  • 00841983101328 ()
QP-947BK

  • Evoked-potential graphic recording system
SOFTWARE, QUANT EMG , MEB-9400
NIHON KOHDEN AMERICA, INC.
QP-946BK
In Commercial Distribution

  • 00841983101311 ()
QP-946BK

  • Evoked-potential graphic recording system
EEG examination support software
NIHON KOHDEN AMERICA, INC.
QP-150AK
In Commercial Distribution

  • 00841983101281 ()
QP-150AK

  • Electroencephalograph
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