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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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the Wand Handpiece - 10618874000124

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-301
In Commercial Distribution

  • 10618874000124 ()
  • 00618874503017 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 10618874000117

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-2725
In Commercial Distribution

  • 10618874000117 ()
  • 00618874502713 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 10618874000100

the Wand Handpiece without needle
Milestone Scientific Inc.
WA-2050A
In Commercial Distribution

  • 10618874000100 ()
  • 00618874025014 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 10618874000094

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-305
In Commercial Distribution

  • 10618874000094 ()
  • 00618874403058 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 10618874000087

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-301
In Commercial Distribution

  • 10618874000087 ()
  • 00618874403010 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 10618874000070

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-2725
In Commercial Distribution

  • 10618874000070 ()
  • 00618874402716 ()


  • Dental computer assisted anaesthesia injection handpiece

Safety Wand STA Handpiece - 10618874000063

SAFETY WAND STA Handpiece without needle
Milestone Scientific Inc.
STA-5040ASAF
In Commercial Distribution

  • 10618874000063 ()
  • 00618874120405 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000056

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-305
In Commercial Distribution

  • 10618874000056 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000049

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-301
In Commercial Distribution

  • 10618874000049 ()
  • 00618874603014 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000032

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-2725
In Commercial Distribution

  • 10618874000032 ()
  • 00618874602710 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000025

STA Handpiece without needle
Milestone Scientific Inc.
STA-5050A
In Commercial Distribution

  • 10618874000025 ()
  • 00618874125011 ()


  • Dental computer assisted anaesthesia injection handpiece

Vyaire - 54250892905711

Vyntus WALK
Jaeger Medical GmbH
V-178501-CT
In Commercial Distribution

  • 54250892905711 ()
V-178501-CT

  • Cardiopulmonary stress exercise monitoring system computer

Vyaire - 54250892904899

Vyntus WALK
Jaeger Medical GmbH
V-178501
In Commercial Distribution

  • 54250892904899 ()
V-178501

  • Cardiopulmonary stress exercise monitoring system computer

Jaeger - 54250892900570

Vyntus WALK
Jaeger Medical GmbH
V-178501
Not in Commercial Distribution

  • 54250892900570 ()
V-178501

  • Cardiopulmonary stress exercise monitoring system computer

CompuDent STA - 00618874000011

STA Instrument
TRICOR SYSTEMS, INC.
STA-5110
In Commercial Distribution

  • 00618874000011 ()


  • Dental computer assisted anaesthesia injection unit

Norav 1200 Series PC-ECG - 07290110252786

Norav 1200 Series PC-ECG Software Upgrade Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2toS2
In Commercial Distribution

  • 07290110252786 ()
HASP-SW-K-S2-S1-01

  • Cardiopulmonary stress exercise monitoring system computer

Norav 1200 Series PC-ECG - 07290110252779

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2
In Commercial Distribution

  • 07290110252779 ()
HASP-SW-K-S2-01

  • Cardiopulmonary stress exercise monitoring system computer

Norav 1200 Series PC-ECG - 07290110252762

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S1
In Commercial Distribution

  • 07290110252762 ()
HASP-SW-K-S1-01

  • Cardiopulmonary stress exercise monitoring system computer

SAFETY WAND Handpiece - 20618874000176

SAFETY WAND Handpiece with needle
Milestone Scientific Inc.
WA-2040 SAF-305
In Commercial Distribution

  • 20618874000176 ()
  • 00618874433055 ()


  • Dental computer assisted anaesthesia injection handpiece

SAFETY WAND Handpiece - 20618874000169

SAFETY WAND Handpiece with needle
Milestone Scientific Inc.
WA-2040 SAF-301
In Commercial Distribution

  • 20618874000169 ()
  • 00618874433017 ()


  • Dental computer assisted anaesthesia injection handpiece

SAFETY WAND Handpiece - 20618874000152

SAFETY WAND WA Handpiece with needle
Milestone Scientific Inc.
WA-2040 SAF-2725
In Commercial Distribution

  • 20618874000152 ()
  • 00618874432713 ()


  • Dental computer assisted anaesthesia injection handpiece

Safety Wand Handpiece - 20618874000145

SAFETY WAND WA Handpiece without needle
Milestone Scientific Inc.
WA-2040ASAF
In Commercial Distribution

  • 20618874000145 ()
  • 00618874024802 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 20618874000138

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-305
In Commercial Distribution

  • 20618874000138 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 20618874000121

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-301
In Commercial Distribution

  • 20618874000121 ()
  • 00618874603014 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 20618874000114

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-2725
In Commercial Distribution

  • 20618874000114 ()
  • 00618874602710 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 20618874000107

WA Handpiece without needle
Milestone Scientific Inc.
WA-2050A
In Commercial Distribution

  • 20618874000107 ()
  • 00618874028015 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 20618874000091

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-305
In Commercial Distribution

  • 20618874000091 ()
  • 00618874413057 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 20618874000084

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-301
In Commercial Distribution

  • 20618874000084 ()
  • 00618874413019 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 20618874000077

SAFETY WAND STA Handpiece with needle
Milestone Scientific Inc.
STA-5040 SAF-2725
In Commercial Distribution

  • 20618874000077 ()
  • 00618874412715 ()


  • Dental computer assisted anaesthesia injection handpiece

Saftey Wand STA Handpiece - 20618874000060

SAFETY WAND STA Handpiece without needle
Milestone Scientific Inc.
STA-5040ASAF
In Commercial Distribution

  • 20618874000060 ()
  • 00618874124809 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 20618874000053

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-305
In Commercial Distribution

  • 20618874000053 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 20618874000046

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-301
In Commercial Distribution

  • 20618874000046 ()
  • 00618874603014 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 20618874000039

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-2725
In Commercial Distribution

  • 20618874000039 ()
  • 00618874602710 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 20618874000022

STA Handpiece without needle
Milestone Scientific Inc.
STA-5050A
In Commercial Distribution

  • 20618874000022 ()
  • 00618874128012 ()


  • Dental computer assisted anaesthesia injection handpiece

CompuDent STA - 20618874000015

STA Instrument
TRICOR SYSTEMS, INC.
STA-5110
In Commercial Distribution

  • 20618874000015 ()
  • 10618874000011 ()


  • Dental computer assisted anaesthesia injection unit

NON-MYDRIATIC AUTO FUNDUS CAMERA - 04987669100554

The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.
NIDEK CO.,LTD.
AFC-330
In Commercial Distribution

  • 04987669100554 ()


  • Ophthalmic fundus camera
  • Eye anterior segment analyser software
  • Posterior eye segment analyser software

N/A - 00851725007160

No Audio Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7450
In Commercial Distribution

  • 00851725007160 ()
RNS-6804-7450

  • Centralized patient monitor

N/A - 00851725007146

No Audio Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-3464
In Commercial Distribution

  • 00851725007146 ()
RNS-6804-3464

  • Centralized patient monitor

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

WAVESCAN OFFLINE PROGRAMMING MODULE - 05050474591905

INSTALL CD,WS 3.68,OPM,US
JOHNSON & JOHNSON SURGICAL VISION, INC.
0070-2533
Not in Commercial Distribution

  • 05050474591905 ()
0070-2533

  • Laser application software

Fisher & Paykel Healthcare - 09420012424266

F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON203
In Commercial Distribution

  • 09420012429100 ()
  • 09420012424266 ()
900ICON203

  • Digital storage media

Fisher & Paykel Healthcare - 09420012423115

F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON202
In Commercial Distribution

  • 09420012427854 ()
  • 09420012423115 ()
900ICON202

  • Digital storage media

Fisher & Paykel Healthcare - 09420012421524

SMARTSTICK-5 PACK HC254
FISHER & PAYKEL HEALTHCARE LIMITED
900HC611
In Commercial Distribution

  • 09420012421524 ()
900HC611

  • Digital storage media

Leica Biosystems RDX QUICKSTOR 8863 USB3 - 00849832013235

Leica Biosystems RDX QUICKSTOR 8863 USB3
Leica Biosystems Richmond, Inc.
23RDX8863
Not in Commercial Distribution

  • 00849832013235 ()

  • Device Size Text, specify:


  • Digital storage media

Leica Biosystems CytoVision Removable Archive Device - 00849832005155

Leica Biosystems Cytovision Removable Archive Device
Leica Biosystems Richmond, Inc.
23STR003XXX001
Not in Commercial Distribution

  • 00849832005155 ()

  • Device Size Text, specify:


  • Digital storage media

NA - 04582275250428

No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • Eye anterior segment analyser software

N'Vision® - 00643169425545

CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL
MEDTRONIC, INC.
8580
In Commercial Distribution

  • 00643169425545 ()


  • Digital storage media

ML 830® - 00859626006282

SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution

  • 00859626006282 ()
ML-830-07-003

  • Laser application software

ML 830® - 00859626006190

DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application software

TearCheck T - 03662824003048

No Description
E-SWIN
N040US000A08A
In Commercial Distribution

  • 03662824003048 ()


  • Corneal topography system analyser
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