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
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 4343W
In Commercial Distribution

  • 06970597832022 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 3643W
In Commercial Distribution

  • 06970597831049 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
EverestView 4343X
In Commercial Distribution

  • 06970597830752 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800RF
In Commercial Distribution

  • 06970597830271 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.7
In Commercial Distribution

  • 00854344007634 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose
100NX DUO Upgrade Kit with VELOCITY
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10137V
In Commercial Distribution

  • 10705037068173 ()
10137V

  • Plasma sterilizer
  • Instrument tray, reusable
Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX2
In Commercial Distribution

  • 08809460309867 ()
IOX2

  • Dental digital imaging sensor, intraoral
Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX1
In Commercial Distribution

  • 08809460309850 ()
IOX1

  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR
SIRONA DENTAL, INC.
B1316200
In Commercial Distribution

  • D764B13162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR
SIRONA DENTAL, INC.
B1216200
In Commercial Distribution

  • D764B12162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR
SIRONA DENTAL, INC.
B1116200
In Commercial Distribution

  • D764B11162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005575
In Commercial Distribution

  • D7641000055751 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005574
In Commercial Distribution

  • D7641000055741 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005573
In Commercial Distribution

  • D7641000055731 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005572
In Commercial Distribution

  • D7641000055721 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005571
In Commercial Distribution

  • D7641000055711 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005570
In Commercial Distribution

  • D7641000055701 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005567
In Commercial Distribution

  • D7641000055671 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005566
In Commercial Distribution

  • D7641000055661 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005565
In Commercial Distribution

  • D7641000055651 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005420
In Commercial Distribution

  • D7641000054201 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005419
In Commercial Distribution

  • D7641000054191 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005418
In Commercial Distribution

  • D7641000054181 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005412
In Commercial Distribution

  • D7641000054121 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral
Image-intensified fluoroscopic x-ray system, mobile
Ziehm-Orthoscan, Inc.
1000-0004-FD
In Commercial Distribution

  • B22510000004FD0 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CLA-001
In Commercial Distribution

  • 10855068008423 ()
CLA-001

  • Surgical screwdriver, reusable
Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CSA-001
In Commercial Distribution

  • 10855068008409 ()
CSA-001

  • Surgical screwdriver, reusable
PLASTIC FILLING W3 PFIW3
Power Dental U.S.A. Inc.
P2909
In Commercial Distribution

  • D943P29090 ()
P2909

  • Margin finishing dental file/rasp, reusable
  • Dental spatula, reusable
  • Dental material application tool, single-use
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472905 ()


  • Computed radiography digital imaging scanner
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472882 ()


  • Computed radiography digital imaging scanner
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410343816 ()


  • Computed radiography digital imaging scanner
Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital
XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital
Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

  • Stationary basic diagnostic x-ray system, digital
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