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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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
CSPOLA600 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 CSPOLA600 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600 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.
CSPOLA600
In Commercial Distribution

  • 08800074500114 ()
CSPOLA600

  • Visual acuity light box
No Description
VIEW-M TECHNOLOGY CO., LTD.
SCS-3200
In Commercial Distribution

  • 08800074500046 ()
SCS-3200

  • Visual acuity light box
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
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
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
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
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue.
RecensMedical, Inc.
RM-DT02W
In Commercial Distribution

  • 08800073100018 ()


  • General cryosurgical system, cryogen gas, mechanical
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
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
F1417MCW
In Commercial Distribution

  • 08800070400043 ()


  • Indirect flat panel x-ray detector
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
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
A1717MCW
In Commercial Distribution

  • 08800070400029 ()


  • Indirect flat panel x-ray detector
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
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
HAD1417MCW
In Commercial Distribution

  • 08800070400005 ()
HAD1417MCW

  • Indirect flat panel x-ray detector
No Description
DynaMedic Co.,Ltd.
DMP-7000S
In Commercial Distribution

  • 08800201101931 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
DynaMedic Co.,Ltd.
DBD111
In Commercial Distribution

  • 08800201100293 ()
  • 18800201100290 ()
  • 28800201100297 ()
  • 38800201100294 ()

  • Width: 25.4 Millimeter
  • Length: 100 Millimeter
  • Height: 1.27 Millimeter


  • Surgical saw blade, oscillating, single-use
No Description
DynaMedic Co.,Ltd.
DMP-7000M
In Commercial Distribution

  • 08800201100002 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P16665-03A
In Commercial Distribution

  • 00841517100513 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P16665-03
In Commercial Distribution

  • 00841517100506 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07696-70A
In Commercial Distribution

  • 00841517100490 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07696-70
In Commercial Distribution

  • 00841517100483 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P12742-70A
In Commercial Distribution

  • 00841517100476 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P12742-70
In Commercial Distribution

  • 00841517100469 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P19626-10
In Commercial Distribution

  • 00841517100452 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07691-70A
In Commercial Distribution

  • 00841517100445 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07691-70
In Commercial Distribution

  • 00841517100438 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07690-71
In Commercial Distribution

  • 00841517100414 ()


  • Rectal/vaginal ultrasound imaging transducer
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P20679-10
In Commercial Distribution

  • 00841517100407 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
FUJIFILM SONOSITE, INC.
P17000-15C
In Commercial Distribution

  • 00841517100261 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16871-26
In Commercial Distribution

  • 00841517100193 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-26
In Commercial Distribution

  • 00841517100186 ()


  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P12822-31
In Commercial Distribution

  • 00841517100087 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12738-31
In Commercial Distribution

  • 00841517100063 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07678-70
In Commercial Distribution

  • 00841517100056 ()


  • General-purpose ultrasound imaging system
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P17000-15
In Commercial Distribution

  • 00841517100032 ()


  • General-purpose ultrasound imaging system
  • Breast ultrasound imaging system
  • Obstetrical/gynaecological ultrasound imaging system
  • Cardiovascular ultrasound imaging system
Diagnostic ultrasound system- transducer
FUJIFILM SONOSITE, INC.
P29671-21
In Commercial Distribution

  • 00841517100018 ()
P29671

  • Extracorporeal ultrasound imaging transducer, hand-held
THERMOQUICK is a battery-powered, non-contact infrared thermometer intended to be used to monitor the body temperature of people of all ages. The reference body site of the output temperature is the axilla. A sensor built into the product measures the infrared energy emitted from the skin surface of the forehead within 2cm, so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages.
T&R BIOFAB CO.,LTD
MT-3000
In Commercial Distribution

  • 08800065228287 ()
  • 08800065226726 ()
  • 08800065225781 ()
MT-3000

  • Infrared patient thermometer, skin
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P20830-18
In Commercial Distribution

  • 00841517101572 ()
P20830

  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-26R
In Commercial Distribution

  • 00841517101558 ()
P16535

  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-13R
In Commercial Distribution

  • 00841517101541 ()
P16535

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P21981-10A
In Commercial Distribution

  • 00841517101480 ()
P21981

  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16871-14R
In Commercial Distribution

  • 00841517101473 ()
P16871

  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16871-14
In Commercial Distribution

  • 00841517101466 ()
P16871

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P12834-40
In Commercial Distribution

  • 00841517101459 ()
P12834

  • General-purpose ultrasound imaging system
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P20830-17
In Commercial Distribution

  • 00841517101442 ()
P20830

  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P19360-17A
In Commercial Distribution

  • 00841517101435 ()
P19360

  • Extracorporeal ultrasound imaging transducer, hand-held
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P18800-15A
In Commercial Distribution

  • 00841517101428 ()
P18800

  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
FUJIFILM SONOSITE, INC.
P20883-12
In Commercial Distribution

  • 00841517101411 ()


  • General-purpose ultrasound imaging system
Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P20680-11
In Commercial Distribution

  • 00841517101404 ()


  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P20500-12
In Commercial Distribution

  • 00841517101398 ()


  • General-purpose ultrasound imaging system
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