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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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BD Multiset™ - 00382903431168

Simulset Version 3.1 Software
BECTON, DICKINSON AND COMPANY
343116
Not in Commercial Distribution

  • 00382903431168 ()
343116

  • Laboratory instrument/analyser application software IVD

BD FACSComp™ - 00382903431151

FACSComp Version 4.0 Software
BECTON, DICKINSON AND COMPANY
343115
Not in Commercial Distribution

  • 00382903431151 ()
343115

  • Laboratory instrument/analyser application software IVD

Natus - 00382830061957

Natus Elite Software - Viking
NATUS NEUROLOGY INCORPORATED
033416
In Commercial Distribution

  • 00382830061957 ()


  • Electromyograph

Natus - 00382830061940

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

  • 00382830061940 ()


  • Electromyograph

Spine & Trauma 3D Navigation - 04056481142025

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

  • 04056481142025 ()


  • Robotic surgical navigation system

MAXFRAME - 10886982308641

MAXFRAME(TM) 2.0 SOFTWARE
Synthes GmbH
03.312.002
In Commercial Distribution

  • 07612334226563 ()
  • 10886982308641 ()
03312002

  • External orthopaedic fixation frame calculation software

Midmark Progeny Imaging Software - 00841709101410

X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101403

X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101397

X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101380

X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101373

X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software

OMNIBotics - 00841690194422

Software Package, AS 2.3
Omni Life Science, Inc.
NS-27111
In Commercial Distribution

  • 00841690194422 ()
NS-27111

  • Robotic surgical navigation system application software

MAXFRAME - 10886982346896

MAXFRAME AUTOSTRUT (TM) SOFTWARE
Synthes GmbH
03.312.003
In Commercial Distribution

  • 10886982346896 ()
03312003

  • External orthopaedic fixation frame calculation software

MAXFRAME - 10886982340832

MAXFRAME AUTOSTRUT(TM) SOFTWARE
SYNTHES (U.S.A.) LP
1110005-01
In Commercial Distribution

  • 10886982340832 ()
111000501

  • External orthopaedic fixation frame calculation software

syngo Dynamics - 04056869253244

syngo Dynamics VA40 Software
Siemens Healthcare GmbH
10745960
In Commercial Distribution

  • 04056869253244 ()


  • Radiological PACS software

Orthex - 00841731119209

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

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software

Care Orchestrator - 00606959052239

Care Orchestrator Software, Netherlands
Respironics, Inc.
1.14
In Commercial Distribution

  • 00606959052239 ()
1136535

  • Medical equipment clinical data interfacing software

Somnolyzer - 00606959006164

Somnolyzer Software Service 24x7
Respironics, Inc.
Somnolyzer Software Service 24x7 - 2
In Commercial Distribution

  • 00606959006164 ()
1084709

  • Polysomnography analyser

Baha - 09321502032834

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

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set

Baha - 09321502026383

Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set
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