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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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No Description
Heidelberg Engineering GmbH
VAO
In Commercial Distribution

  • 04059237000112 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.6
In Commercial Distribution

  • 04059237000105 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3610
In Commercial Distribution

  • 04059237000099 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S1610
In Commercial Distribution

  • 04059237000082 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-TSP
In Commercial Distribution

  • 04059237000075 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2001A
In Commercial Distribution

  • 04059237000068 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2000A
In Commercial Distribution

  • 04059237000051 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SP-PWS-1000A
In Commercial Distribution

  • 04059237000044 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3600
In Commercial Distribution

  • 04059237000037 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2000
In Commercial Distribution

  • 04059237000020 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S1600
In Commercial Distribution

  • 04059237000013 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
S2610 [SN>20000]
In Commercial Distribution

  • 04059237000792 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2001A [>20000]
In Commercial Distribution

  • 04059237000716 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.12_US
In Commercial Distribution

  • 04059237000594 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.10-US
In Commercial Distribution

  • 04059237000549 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.14_US
In Commercial Distribution

  • 04059237000488 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.9.1-US
In Commercial Distribution

  • 04059237000341 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.8a-US
In Commercial Distribution

  • 04059237000310 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.8-US
Not in Commercial Distribution

  • 04059237000303 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2600
In Commercial Distribution

  • 04059237000280 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0300
In Commercial Distribution

  • 00858184006062 ()


  • Gait-enhancement electrical stimulation system, external
Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0310
In Commercial Distribution

  • 00858184006055 ()


  • Gait-enhancement electrical stimulation system, external
E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display);
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265057 ()
ESWKST-DAA-AXXXX

  • Patient health record information system application software
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution

  • 07640153470157 ()
ST8000

  • Ocular volume ambulatory recording system software
No Description
Ablenet, Inc.
10000053
In Commercial Distribution

  • 00850011150276 ()
10000053

  • Assistive human interface device proximal control, hand-operated
REMOVABLE HARD DRIVES FOR 7245C
PENTAX OF AMERICA, INC.
7202B
In Commercial Distribution

  • 04961333231614 ()


  • Manometric gastrointestinal motility analysis system
DIGITAL SWALLOWING CABLE
PENTAX OF AMERICA, INC.
7184-5900
In Commercial Distribution

  • 04961333231386 ()


  • Manometric gastrointestinal motility analysis system
THREE BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9900
In Commercial Distribution

  • 04961333231362 ()


  • Manometric gastrointestinal motility analysis system
TWO BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9800
In Commercial Distribution

  • 04961333231355 ()


  • Manometric gastrointestinal motility analysis system
EMG CABLE,6' (1250-0334)
PENTAX OF AMERICA, INC.
7180-2102
In Commercial Distribution

  • 04961333231348 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system
EMG CABLE,6' (1250-0335)
PENTAX OF AMERICA, INC.
7180-2101
In Commercial Distribution

  • 04961333231331 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system
SYNC MODULE FOR PAL 230V
PENTAX OF AMERICA, INC.
7127E
Not in Commercial Distribution

  • 04961333231317 ()


  • Manometric gastrointestinal motility analysis system
SWALLOWING UPGRADE
PENTAX OF AMERICA, INC.
7120B-2
Not in Commercial Distribution

  • 04961333231300 ()


  • Manometric gastrointestinal motility analysis system
ANALOG-DIGITAL CONVERT DFG/SV1
PENTAX OF AMERICA, INC.
1111-1582
In Commercial Distribution

  • 04961333231188 ()


  • Manometric gastrointestinal motility analysis system
MONITOR, ACER V196L 19" LCD
PENTAX OF AMERICA, INC.
1111-1420
In Commercial Distribution

  • 04961333231171 ()


  • Manometric gastrointestinal motility analysis system
SYNC MODULE FOR FULL SYSTEM
PENTAX OF AMERICA, INC.
7127
Not in Commercial Distribution

  • 04961333231089 ()


  • Manometric gastrointestinal motility analysis system
TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system
Tongue Arrays
PENTAX OF AMERICA, INC.
7183-4500
In Commercial Distribution

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system
Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system
Laryngeal Microphone
PENTAX OF AMERICA, INC.
7126
In Commercial Distribution

  • 04961333229956 ()


  • Manometric gastrointestinal motility analysis system
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