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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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 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
FONA STELLARIS S1 SENSOR
SIRONA DENTAL, INC.
B1116200
In Commercial Distribution

  • D764B11162000 ()


  • Dental digital imaging sensor, intraoral
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
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
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
Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

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

  • 00195278070265 ()
B2402CAB

  • Stationary basic diagnostic x-ray system, digital
Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital
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