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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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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
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
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
XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital
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