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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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Scanmate Flex USB Interface - 00857377006117

The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.
DGH TECHNOLOGY INC.
Scanmate Flex
In Commercial Distribution

  • 00857377006117 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system

Scanmate B - 00857377006100

The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
DGH TECHNOLOGY INC.
DGH 8000
In Commercial Distribution

  • 00857377006100 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system

ECHOSCAN - 04987669100455

The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis. Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.
NIDEK CO.,LTD.
US-500
In Commercial Distribution

  • 04987669100455 ()


  • Ophthalmic ultrasound imaging system
  • Ultrasound pachymeter

ECHOSCAN - 04987669100448

Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are applied, and these types of high sound waves have the following characteristics similar to light: They have a high tendency to travel in a straight direction. They have characteristics such as reflect.
NIDEK CO.,LTD.
US-4000
In Commercial Distribution

  • 04987669100448 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system

4Sight - 00897826002079

No Description
ACCUTOME, INC.
24-8000
In Commercial Distribution

  • 00897826002079 ()
24-8000

  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system

Ultrasonic Biometer for Ophthalmology - 06948941111123

MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
Meda Co., Ltd
MD-1000A/P
In Commercial Distribution

  • 06948941111123 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system

Welch Allyn, Inc. - 00732094264029

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264029 ()
HSCRIBE-6AC-DXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263183

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; No lead set; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263183 ()
QS-6XC-BXXXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094257748

XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259476

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259476 ()
XSCRIBE-6CC-XXXXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094301564

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301564 ()
HSCRIBWS-6AA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094286137

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286137 ()
HSCRIBE-6AD-ZXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264098

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264098 ()
HSCRIBE-6AC-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264074

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264074 ()
HSCRIBE-6AC-CXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

TIMS System - 00850951007272

TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev L
Not in Commercial Distribution

  • 00850951007272 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007104

TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev K
Not in Commercial Distribution

  • 00850951007104 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation

VAR Surgical Center Kit - 20637320050503

Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung
VORTRAN MEDICAL TECHNOLOGY 1, INC
PCK-5050
In Commercial Distribution

  • 20637320050503 ()
PCK-5050

  • Pulmonary resuscitator, pneumatic, single-use

Welch Allyn, Inc. - 00732094259032

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259032 ()
XSCRIBE-6XC-XXXXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094338812

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094338812 ()
HSCRIBE-6AC-CXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094309478

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU, no display; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094309478 ()
HSCRIBE-6AB-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264081

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264081 ()
HSCRIBE-6AC-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264043

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264043 ()
HSCRIBE-6AC-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

MicroScan - 15099590703271

CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590703110 ()
  • 15099590703271 ()
  • 15099590703127 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

Welch Allyn, Inc. - 00732094262421

Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262421 ()
SCREV-AAB-BXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094285444

Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094285444 ()
SCREP-AAB-XXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262391

Surveyor Central Review Station - Italian language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262391 ()
SCREV-AEB-BXXXX

  • Centralized patient monitor

MAESTRO 8.0 CD - 09008737380625

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38062
In Commercial Distribution

  • 09008737380625 ()


  • Audiometric/hearing device software

SFG Sperm CD - 10850068289520

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS3
In Commercial Distribution

  • 00850068289523 ()
  • 10850068289520 ()


  • Assisted reproduction procedure dish

SFG Sperm CD - 10850068289513

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS2
In Commercial Distribution

  • 00850068289516 ()
  • 10850068289513 ()


  • Assisted reproduction procedure dish

SFG Sperm CD - 10850068289506

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS1
In Commercial Distribution

  • 00850068289509 ()
  • 10850068289506 ()


  • Assisted reproduction procedure dish

LTA Check CD - G0561071490

No Description
Bio/Data Corporation
107149
In Commercial Distribution

  • G0561071490 ()
107149

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

PAP-8E Software CD - G0561071530

No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD

POWERCHO-2 CD, 100L - 00840075402763

No Description
Lonza Walkersville, Inc.
08-911D
In Commercial Distribution

  • 00840075402763 ()
08-911D

  • Ex vivo cell culture medium

Noxturnal PSG CD - 15694311111368

No Description
Nox Medical ehf.
NOX-NOXTPSG_CD
In Commercial Distribution

  • 15694311111368 ()
539012

  • Sleep disorder interpretive software, professional-only

CMSViewer CD(FDA) - 06944904086422

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034054-00
In Commercial Distribution

  • 06944904086422 ()


  • Noninvasive device battery charger

Welch Allyn, Inc. - 00732094259711

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259711 ()
XSCRIBE-6CC-CXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259513

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259513 ()
XSCRIBE-6CC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259483

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259483 ()
XSCRIBE-6CC-XXBXX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094259360

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259360 ()
XSCRIBE-6DC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259056

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259056 ()
XSCRIBE-6XC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259049

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259049 ()
XSCRIBE-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094323191

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094323191 ()
HSCRIBE-6AD-ZXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094318166

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318166 ()
XSCRIBE-6XC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094264050

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264050 ()
HSCRIBE-6AC-DXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264036

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264036 ()
HSCRIBE-6AC-DXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Alpine BioMed - 05704736016810

"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


  • Electromyograph

GIOTTO IMAGE 3DL - 08033837190035

MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
MAW
In Commercial Distribution

  • 08033837190035 ()
  • 18033837190032 ()

  • Height: 1920 Millimeter
  • Depth: 470 Millimeter
  • Width: 1175 Millimeter
6006-15GM3

  • Radiology DICOM image processing application software

Summit Doppler - 00888937011357

Vantage ABI System Contents: Two 10 cm cuffs, two 12cm cuffs, four color-coded hoses, reporting software CD and USB memory stick.
Coopersurgical, Inc.
VANABI
In Commercial Distribution

  • 00888937011357 ()


  • Noninvasive vascular ultrasound system

Welch Allyn, Inc. - 00732094345643

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094345643 ()
HSCRIBE-6AC-DXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094259599

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259599 ()
XSCRIBE-6CC-DXAXX

  • Cardiopulmonary stress exercise monitoring system computer
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