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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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L25x/13-6 MHz - 00841517100438

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07691-70
In Commercial Distribution

  • 00841517100438 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

ICTx/8-5 MHz - 00841517100421

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07690-71A
In Commercial Distribution

  • 00841517100421 ()


  • Rectal/vaginal ultrasound imaging transducer

ICTx/8-5 MHz - 00841517100414

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07690-71
In Commercial Distribution

  • 00841517100414 ()


  • Rectal/vaginal ultrasound imaging transducer

HSL25x/13-6 MHz - 00841517100407

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20679-10
In Commercial Distribution

  • 00841517100407 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

C60xi/5-2 MHz - 00841517100391

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20402-10A
In Commercial Distribution

  • 00841517100391 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

C60xi/5-2 MHz - 00841517100384

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20402-10
In Commercial Distribution

  • 00841517100384 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL38xi/13-6 MHz - 00841517100377

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20311-10A
In Commercial Distribution

  • 00841517100377 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL38xi/13-6 MHz - 00841517100360

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20311-10
In Commercial Distribution

  • 00841517100360 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL50x/15-6 MHz - 00841517100353

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07693-70A
In Commercial Distribution

  • 00841517100353 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL50x/15-6 MHz - 00841517100346

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07693-70
In Commercial Distribution

  • 00841517100346 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL38x/13-6 MHz - 00841517100339

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07682-70A
In Commercial Distribution

  • 00841517100339 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HFL38x/13-6 MHz - 00841517100322

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07682-70
In Commercial Distribution

  • 00841517100322 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

C60x/5-2 MHz - 00841517100315

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07680-70A
In Commercial Distribution

  • 00841517100315 ()
P07680

  • Extracorporeal ultrasound imaging transducer, hand-held

C60x/5-2 MHz - 00841517100308

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07680-70
In Commercial Distribution

  • 00841517100308 ()
P07680

  • Extracorporeal ultrasound imaging transducer, hand-held

C11x/8-5 MHz - 00841517100292

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07678-70A
In Commercial Distribution

  • 00841517100292 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

SonoSite S-Series - 00841517100285

No Description
FUJIFILM SONOSITE, INC.
P09417-93R
In Commercial Distribution

  • 00841517100285 ()


  • General-purpose ultrasound imaging system

SonoSite S-Series - 00841517100278

No Description
FUJIFILM SONOSITE, INC.
P09417-93
In Commercial Distribution

  • 00841517100278 ()


  • General-purpose ultrasound imaging system

SonoSite M-Turbo - 00841517100261

No Description
FUJIFILM SONOSITE, INC.
P17000-15C
In Commercial Distribution

  • 00841517100261 ()


  • General-purpose ultrasound imaging system

SonoSite M-Turbo - 00841517100254

No Description
FUJIFILM SONOSITE, INC.
P17000-15R
In Commercial Distribution

  • 00841517100254 ()


  • General-purpose ultrasound imaging system

SonoSite Edge - 00841517100247

No Description
FUJIFILM SONOSITE, INC.
P15000-64R
In Commercial Distribution

  • 00841517100247 ()


  • General-purpose ultrasound imaging system

SonoSite Edge - 00841517100230

No Description
FUJIFILM SONOSITE, INC.
P15000-64
In Commercial Distribution

  • 00841517100230 ()


  • General-purpose ultrasound imaging system

SonoSite SII - 00841517100216

No Description
FUJIFILM SONOSITE, INC.
P20500-10
In Commercial Distribution

  • 00841517100216 ()


  • General-purpose ultrasound imaging system

Triple Transducer Connect - 00841517100186

Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-26
In Commercial Distribution

  • 00841517100186 ()


  • General-purpose ultrasound imaging system

Triple Transducer Connect - 00841517100179

Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-13
In Commercial Distribution

  • 00841517100179 ()


  • General-purpose ultrasound imaging system

Triple Transducer Connect - 00841517100131

Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-51
In Commercial Distribution

  • 00841517100131 ()


  • General-purpose ultrasound imaging system

SII Stand - 00841517100124

Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P21432-04
In Commercial Distribution

  • 00841517100124 ()


  • General-purpose ultrasound imaging system

Power Pack - 00841517100100

No Description
FUJIFILM SONOSITE, INC.
P13122-02
In Commercial Distribution

  • 00841517100100 ()
P13122

  • General-purpose ultrasound imaging system

Power Park - 00841517100094

No Description
FUJIFILM SONOSITE, INC.
P12834-31
In Commercial Distribution

  • 00841517100094 ()


  • General-purpose ultrasound imaging system

Power Park - 00841517100087

No Description
FUJIFILM SONOSITE, INC.
P12822-31
In Commercial Distribution

  • 00841517100087 ()


  • General-purpose ultrasound imaging system

H-Universal Stand - 00841517100070

Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12163-13
In Commercial Distribution

  • 00841517100070 ()


  • General-purpose ultrasound imaging system

V-Universal Stand - 00841517100063

Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12738-31
In Commercial Distribution

  • 00841517100063 ()


  • General-purpose ultrasound imaging system

C11x/8-5 MHz - 00841517100056

Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07678-70
In Commercial Distribution

  • 00841517100056 ()


  • General-purpose ultrasound imaging system

Cerviray - 08800126000050

The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only.
AIDOT
ADT-CC10
In Commercial Distribution

  • 08800126000050 ()
  • 18800126000057 ()
D-23-090

  • Colposcope

CLAROX - 08800124900000

CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.
VSI Co., Ltd.
VX-30
In Commercial Distribution

  • 18800124900007 ()
  • 08800124900000 ()
VX-30

  • Hand-held intraoral dental x-ray system, digital

CODMAN HAKIM - 10886704041597

CODMAN HAKIM Valve Programmer, 100-240V
Cerenovus, Inc.
82-3190
Not in Commercial Distribution

  • 10886704041597 ()
823190

  • Cerebrospinal fluid shunt valve programmer

CODMAN HAKIM - 10886704078616

CODMAN HAKIM Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage conditions. Temperature -40 DEGREES C - +60 DEGREES C Relative Humidity 10 Percent - 85 Percent Atmospheric Pressure 500hPa - 1060hPa
Cerenovus, Inc.
823190R
Not in Commercial Distribution

  • 10886704078616 ()
823190R

  • Cerebrospinal fluid shunt valve programmer

CODMAN VPV - 10886704078609

CODMAN VPV System Contents: One Each: CODMAN VPV Program Unit, CODMAN VPV Transmitter Unit, Power Cord, Ultrasound Gel, Instructions for Use, and Carrying Case
Cerenovus, Inc.
823192R
Not in Commercial Distribution

  • 10886704078609 ()
823192R

  • Cerebrospinal fluid shunt valve programmer

Visual Chart System - 08800074500305

CSPOLA600F is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600F can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600F is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600F
In Commercial Distribution

  • 08800074500305 ()
CSPOLA600F

  • Visual acuity light box

Visual Chart System - 08800074500299

CSPOLA600C is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600C can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600C is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600C
In Commercial Distribution

  • 08800074500299 ()
CSPOLA600C

  • Visual acuity light box

Visual Chart System - 08800074500282

CS550 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CS550 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CS550 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CS550
In Commercial Distribution

  • 08800074500282 ()
CS550

  • Visual acuity light box

Auto Lensmeter - 08800074500251

This device aims to take the measurements of vertex powers, cylinder axis, prismatic power and prism base setting within a restricted area of unprocessed lens, processed framed lens and contact lens, Auto Lensmeter also has functions to measure UV/BLUE transmission. As an external feature, the angle of the LCD can be changed. User is able to measure the PD and OH value with the horizontal and vertical ruler GUI after adjusting the extended LCD at the lowest angle.
VIEW-M TECHNOLOGY CO., LTD.
ALM-1P
In Commercial Distribution

  • 08800074500251 ()
ALM-1P

  • Manually-adjusted lensmeter, line-powered

LCD ACUITY DEVICE - 08800074500152

PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
PROVUE
In Commercial Distribution

  • 08800074500152 ()
PROVUE

  • Visual acuity light box

Visual Chart System - 08800074500046

No Description
VIEW-M TECHNOLOGY CO., LTD.
SCS-3200
In Commercial Distribution

  • 08800074500046 ()
SCS-3200

  • Visual acuity light box

Visual Chart System - 08800074500039

VLC-2400P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400P
In Commercial Distribution

  • 08800074500039 ()
VLC-2400P

  • Visual acuity light box

Visual Chart System - 08800074500022

VLC-2400 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400
In Commercial Distribution

  • 08800074500022 ()
VLC-2400

  • Visual acuity light box

Visual Chart System - 08800074500015

VLC-1900P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900P
In Commercial Distribution

  • 08800074500015 ()
VLC-1900P

  • Visual acuity light box

Visual Chart System - 08800074500008

VLC-1900 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900
In Commercial Distribution

  • 08800074500008 ()
VLC-1900

  • Visual acuity light box

ADD - 08800070400050

The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1717MCW
In Commercial Distribution

  • 08800070400050 ()
HAD1717MCW

  • Indirect flat panel x-ray detector

A1417MCW - 08800070400036

The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
A1417MCW
In Commercial Distribution

  • 08800070400036 ()


  • Indirect flat panel x-ray detector

HAD1717MC - 08800070400012

The HAD1717MC is a wired digital flat panel X-ray detector. The HAD1717MC X-ray detector consists of a TFT panel and a scintillator electronic controller, and supports AED (Automatic Exposure Detection) function that can operate without a separate trigger signal. Flat panel sensors for HAD1717MC are fabricated using thin film technology based on amorphous silicon technology, and the sensors are similar to existing photodiode arrays. In this case, each pixel is composed of a photodiode and a thin film transistor (TFT). Amorphous silicon photodiodes are optimized for green wavelengths and can be used in combination with scintillators such as CsI. The incident X-rays are converted into visible light by the scintillator, and the visible light is stored in an internal capacitor through a photodiode. Charges charged to capacitors switch TFT gates of panel matrix (panel matrix) and convert them into digital signals on a line and pass them to the control unit. The digital data generated is then passed to the PC via Ethernet.
H&abyz Co., Ltd
HAD1717MC
In Commercial Distribution

  • 08800070400012 ()


  • Indirect flat panel x-ray detector
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