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
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
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
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
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
MSS-4581-3D MANOSHIELD 3DAR - BOX 10
Given Imaging, Inc.
MSS-4581-3D
In Commercial Distribution

  • 04260167483719 ()
  • 10884521768062 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, RFG
Given Imaging, Inc.
RFG-1286-EAN
In Commercial Distribution

  • 04260167483597 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, RFG
Given Imaging, Inc.
RFG-3890-EAN
In Commercial Distribution

  • 04260167482989 ()


  • Manometric gastrointestinal motility analysis system
ESO 3D Catheter
Given Imaging, Inc.
RFG-8001
In Commercial Distribution

  • 04260167482637 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, RFG
Given Imaging, Inc.
RFG-1286
In Commercial Distribution

  • 04260167482569 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Regular
Given Imaging, Inc.
RFG-2192
In Commercial Distribution

  • 04260167482552 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Small
Given Imaging, Inc.
RFG-2195
In Commercial Distribution

  • 04260167482545 ()


  • Manometric gastrointestinal motility analysis system
AR 3D Probe
Given Imaging, Inc.
RFG-3885
In Commercial Distribution

  • 04260167482538 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, SD Small
Given Imaging, Inc.
RFG-3886
In Commercial Distribution

  • 04260167482521 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, SD Regular
Given Imaging, Inc.
RFG-3887
In Commercial Distribution

  • 04260167482514 ()


  • Manometric gastrointestinal motility analysis system
ESO Z Catheter
Given Imaging, Inc.
RFG-3890
In Commercial Distribution

  • 04260167482507 ()


  • Manometric gastrointestinal motility analysis system
ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter
Given Imaging, Inc.
1286
In Commercial Distribution

  • 04260167482484 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Regular
Given Imaging, Inc.
2192
In Commercial Distribution

  • 04260167482477 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Small
Given Imaging, Inc.
2195
In Commercial Distribution

  • 04260167482460 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, SD Small
Given Imaging, Inc.
3886
In Commercial Distribution

  • 04260167482453 ()


  • Manometric gastrointestinal motility analysis system
ESO Z Catheter
Given Imaging, Inc.
3890
In Commercial Distribution

  • 04260167482446 ()


  • Manometric gastrointestinal motility analysis system
ESO With Extended Tip
Given Imaging, Inc.
800015
In Commercial Distribution

  • 04260167482439 ()


  • Manometric gastrointestinal motility analysis system
ESO 3D Catheter
Given Imaging, Inc.
FGS-8001
In Commercial Distribution

  • 04260167482422 ()


  • Manometric gastrointestinal motility analysis system
Assy, Retail Box of 20, ManoShield SD
Given Imaging, Inc.
MSS-4360
In Commercial Distribution

  • 04260167482262 ()
  • 10884521742727 ()


  • Manometric gastrointestinal motility analysis system
Assy, Retail Box of 10, ManoShield AR
Given Imaging, Inc.
MSS-3599
In Commercial Distribution

  • 04260167482248 ()
  • 10884521742734 ()


  • Manometric gastrointestinal motility analysis system
Assy, Retail Box of 20, ManoShield EG
Given Imaging, Inc.
MSS-2155
In Commercial Distribution

  • 04260167482200 ()
  • 10884521742741 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, SD Regular
Given Imaging, Inc.
3887
In Commercial Distribution

  • 04260167480961 ()


  • Manometric gastrointestinal motility analysis system
AR 3D Probe
Given Imaging, Inc.
3885
In Commercial Distribution

  • 04260167480954 ()


  • Manometric gastrointestinal motility analysis system
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
FUJIFILM CORPORATION
CR-VW674
In Commercial Distribution

  • 04547410316926 ()


  • Diagnostic x-ray digital imaging system workstation
7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


  • Electrocardiographic ambulatory recorder
5 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100605
In Commercial Distribution

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder
No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder
The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) continuous recording of ambulatory electrocardiograph (AECG) data on a single AAA battery. It has the ability to detect and record pacemaker pulses according to the appropriate criteria for Association for the Advancement of Medical Instrumentation (AAMI) pacer detection.
SCOTTCARE CORPORATION, THE
RZ153C
In Commercial Distribution

  • 00856298006008 ()
101273

  • Electrocardiographic ambulatory recorder
No Description
MEDSPIRA, LLC
RMD-010-005
In Commercial Distribution

  • 00851607003242 ()
  • 10851607003249 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-COM
In Commercial Distribution

  • 00851607003228 ()
  • 10851607003225 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution

  • 00851607003211 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution

  • 00851607003204 ()


  • Manometric gastrointestinal motility analysis system
No Description
Ablenet, Inc.
10000053
In Commercial Distribution

  • 00850011150276 ()
10000053

  • Assistive human interface device proximal control, hand-operated
MANOMETER CABLE
PENTAX OF AMERICA, INC.
7182-2400
In Commercial Distribution

  • 04961333242023 ()


  • Manometric gastrointestinal motility analysis system
MANOMETER CABLE
PENTAX OF AMERICA, INC.
7182-2300
In Commercial Distribution

  • 04961333242016 ()


  • Manometric gastrointestinal motility analysis system
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