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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
LUNEAU TECHNOLOGY OPERATIONS
Nexy
In Commercial Distribution

  • 03664188000381 ()


  • Ophthalmic fundus camera
Scanning Laser Ophthalmoscope
EasyScan B.V.
EasyScan
In Commercial Distribution

  • 08719326032108 ()


  • Ophthalmic fundus camera
No Description
CLASSYS Inc.
DNC-C1
In Commercial Distribution



  • Ophthalmic fundus camera
DESMARRES LID RETR
Avalign Technologies, Inc.
1-350152
In Commercial Distribution

  • 00190776166533 ()


  • Telemetric sphygmomanometer
DESMARRES LID RETR
Avalign Technologies, Inc.
1-350151
In Commercial Distribution

  • 00190776166526 ()


  • Telemetric sphygmomanometer
DESMARRES LID RETR
Avalign Technologies, Inc.
1-350150
In Commercial Distribution

  • 00190776166519 ()


  • Telemetric sphygmomanometer
DESMARRES LID RETR
Avalign Technologies, Inc.
1-3501498
In Commercial Distribution

  • 00190776166502 ()


  • Telemetric sphygmomanometer
DESMARRES LID RETR
Avalign Technologies, Inc.
1-350149
In Commercial Distribution

  • 00190776166496 ()


  • Telemetric sphygmomanometer
MODULAR WEIGHT
Avalign Technologies, Inc.
1-343001
In Commercial Distribution

  • 00190776166472 ()


  • Telemetric sphygmomanometer
Hohmann Retr . Blade
Avalign Technologies, Inc.
1-34160002
In Commercial Distribution

  • 00190776166458 ()


  • Telemetric sphygmomanometer
DEAVER RETRACTOR, . Blade
Avalign Technologies, Inc.
1-3317
In Commercial Distribution

  • 00190776166441 ()


  • Telemetric sphygmomanometer
McBride Retr Toothed Shank Cust Speed Lock
Avalign Technologies, Inc.
1-3316CSL
In Commercial Distribution

  • 00190776166434 ()


  • Telemetric sphygmomanometer
DE LEE UNIVERSAL RETRACTOR . BLADE .
Avalign Technologies, Inc.
1-30340
In Commercial Distribution

  • 00190776166427 ()


  • Telemetric sphygmomanometer
Unger Wide Hohmann with Two Tips Blade
Avalign Technologies, Inc.
1-3008
In Commercial Distribution

  • 00190776166410 ()


  • Telemetric sphygmomanometer
Finochietto Rib Retr Infant wit
Avalign Technologies, Inc.
1-300200
In Commercial Distribution

  • 00190776166403 ()


  • Telemetric sphygmomanometer
Unger Narrow Hohmann Blade wide
Avalign Technologies, Inc.
1-3002
In Commercial Distribution

  • 00190776166397 ()


  • Telemetric sphygmomanometer
The Verily Retinal Camera is an ophthalmic camera used to acquire and transmit digital images of the human eye, including the retina. It is a prescription-use only medical device.
VERILY LIFE SCIENCES LLC
VRC-100
In Commercial Distribution

  • 10860000249543 ()


  • Ophthalmic fundus camera
Double Ended Orbital Retractor, small, 10mm /14mm
Avalign Technologies, Inc.
1-3706
In Commercial Distribution

  • 00190776384876 ()


  • Telemetric sphygmomanometer
Double Ended Orbital Retractor, large, 16mm/ 25mm
Avalign Technologies, Inc.
1-3705
In Commercial Distribution

  • 00190776384869 ()


  • Telemetric sphygmomanometer
Desmarres Lid Retractor, 5 1/2", 15mm, coated
Avalign Technologies, Inc.
1-210196NC
In Commercial Distribution

  • 00190776384845 ()


  • Telemetric sphygmomanometer
Desmarres Lid Retractor, 5 1/2", 11mm, coated
Avalign Technologies, Inc.
1-210194NC
In Commercial Distribution

  • 00190776384838 ()


  • Telemetric sphygmomanometer
ICON Handpiece
NEOLIGHT LLC
PCI 40-1002
In Commercial Distribution

  • 10852788008085 ()


  • Ophthalmic fundus camera
LTE 4G capable
IEM GmbH
GSM plus
In Commercial Distribution

  • 04041346102160 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
size XL
In Commercial Distribution

  • 04041346101231 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
size M
In Commercial Distribution

  • 04041346101217 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
BT plus
In Commercial Distribution

  • 04041346101279 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
GSM plus
In Commercial Distribution

  • 04041346101262 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
size L
In Commercial Distribution

  • 04041346101224 ()


  • Telemetric sphygmomanometer
No Description
IEM GmbH
size S
In Commercial Distribution

  • 04041346101200 ()


  • Telemetric sphygmomanometer
HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution

  • G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01

  • Cognitive assessment software
Desmarres Lid Retractor, size 4, 18mmn, 5 1/2"
Avalign Technologies, Inc.
1-350153
In Commercial Distribution

  • 00190776397494 ()


  • Telemetric sphygmomanometer
Unger Hohmann, Narrow Blade 34mm, 5.5" blade depth
Avalign Technologies, Inc.
1-3002M
In Commercial Distribution

  • 00190776402730 ()


  • Telemetric sphygmomanometer
PRESSIO SERIAL TRANSMITTER
SOPHYSA
PSO-TX00
Not in Commercial Distribution

  • 03760124131512 ()


  • Patient monitoring system module, intracranial pressure
PRESSIO ICP INTERFACE CONTROL UNIT
SOPHYSA
PSO-IN00
Not in Commercial Distribution

  • 03760124131499 ()


  • Patient monitoring system module, intracranial pressure
No Description
Carl Zeiss Meditec AG
302721-9030-000
In Commercial Distribution

  • 04049539072030 ()


  • Ophthalmic fundus camera
No Description
Carl Zeiss Meditec AG
302721-9020-000
In Commercial Distribution

  • 04049539072023 ()


  • Ophthalmic fundus camera
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
Carl Zeiss Meditec AG
VISUCAM 524
In Commercial Distribution

  • 04049471093162 ()

  • Weight: 36 Kilogram
  • Dimension: approx. 400mmx500mmx730mm


  • Ophthalmic fundus camera
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
Carl Zeiss Meditec AG
VISUCAM 224
In Commercial Distribution

  • 04049471093155 ()

  • Dimension: approx. 400mmx500mmx730mm
  • Weight: 36 Kilogram


  • Ophthalmic fundus camera
The FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally.
Carl Zeiss Meditec AG
FF450plus
In Commercial Distribution

  • 04049471093032 ()

  • Dimension Fundus Camera: approx. 310mmx800mmx430mm
  • Dimension NAG: 132mmx440mmx360mm


  • Ophthalmic fundus camera
COBRA FUNDUS CAMERA
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
COBRA
In Commercial Distribution

  • 08056098470319 ()
103303A00 V0/S10

  • Ophthalmic fundus camera
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