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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
1BYONEPRODUCTS INC.
9-JK14US05
In Commercial Distribution

  • 00858069007191 ()
  • 00858069007184 ()
  • 10858069007198 ()


  • Telemetric sphygmomanometer
No Description
1BYONEPRODUCTS INC.
9-JK14US06
In Commercial Distribution

  • 00858069007177 ()
  • 00858069007153 ()
  • 10858069007174 ()


  • Telemetric sphygmomanometer
Wireless Arm Blood Pressure Monitor
1BYONEPRODUCTS INC.
TMB-1585-BT
In Commercial Distribution

  • 10858069007044 ()
  • 00858069007047 ()
  • 00858069007030 ()


  • Telemetric sphygmomanometer
The device is used to observe, capture and record retina images through examining pupil.
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC160
In Commercial Distribution

  • 06945087516010 ()


  • Ophthalmic fundus camera
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC162
In Commercial Distribution

  • 06945087516225 ()


  • Ophthalmic fundus camera
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC161
In Commercial Distribution

  • 06945087516102 ()


  • Ophthalmic fundus camera
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
FC163
In Commercial Distribution

  • 06945087500088 ()


  • Ophthalmic fundus camera
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-004083-00
In Commercial Distribution

  • 06944904086224 ()


  • Patient monitoring system module, intracranial pressure
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-007590-00
In Commercial Distribution

  • 06944904086187 ()


  • Patient monitoring system module, intracranial pressure
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013199-00
In Commercial Distribution

  • 06944904085814 ()


  • Patient monitoring system module, intracranial pressure
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013196-00
In Commercial Distribution

  • 06944904085791 ()


  • Patient monitoring system module, intracranial pressure
The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera
The identifeye Camera System is a fundus ophthalmic camera.
Identifeye Health Inc.
850-30003-00
In Commercial Distribution

  • 00850067214274 ()


  • Ophthalmic fundus camera
identifeye Camera System power supply accessory
Identifeye Health Inc.
815-30020-00
In Commercial Distribution

  • 00850067214236 ()


  • Ophthalmic fundus camera
identifeye Camera System tablet accessory
Identifeye Health Inc.
815-30023-01
In Commercial Distribution

  • 00850067214229 ()


  • Ophthalmic fundus camera
White Light Module
NEOLIGHT LLC
PCI 40-1005
In Commercial Distribution

  • 00852788008071 ()


  • Ophthalmic fundus camera
ICON Footswitch
NEOLIGHT LLC
PCI 30-1000
In Commercial Distribution

  • 00852788008064 ()


  • Ophthalmic fundus camera
ICON GO Control Box
NEOLIGHT LLC
PCI 40-1030
In Commercial Distribution

  • 00852788008057 ()


  • Ophthalmic fundus camera
Diffuser
NEOLIGHT LLC
PCI 40-1017
In Commercial Distribution

  • 00852788008040 ()


  • Ophthalmic fundus camera
FA Module
NEOLIGHT LLC
PCI 40-1004
In Commercial Distribution

  • 00852788008026 ()


  • Ophthalmic fundus camera
ICON Cart Control Box
NEOLIGHT LLC
PCI 40-1003
In Commercial Distribution

  • 00852788008019 ()


  • Ophthalmic fundus camera
Non-mydriatic Auto Fundus Camera
U.S. OPHTHALMIC, L.L.C.
EFC-2600
In Commercial Distribution

  • 00851158007690 ()


  • Ophthalmic fundus camera
DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
41177
In Commercial Distribution

  • 00851434007024 ()


  • Ophthalmic fundus camera
DigiSIght Technologies Inc. Paxos Scope Ophthalmic Camera with optional 20D acrylic lens
DIGISIGHT TECHNOLOGIES, INC.
40807
In Commercial Distribution

  • 00851434007017 ()


  • Ophthalmic fundus camera
DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
40806
In Commercial Distribution

  • 00851434007000 ()


  • Ophthalmic fundus camera
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution

  • 00859942006423 ()
5430-30154

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution

  • 00859942006102 ()
5430-30152

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system
Hand Held Fundus Camera EFC-1800
U.S. OPHTHALMIC, L.L.C.
EFC-1800
In Commercial Distribution

  • 00850038195229 ()


  • Ophthalmic fundus camera
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software
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