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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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OP 3D Vision - D090083081000

V8
Dental Imaging Technologies Corporation
0.830.8100
In Commercial Distribution



  • Cone beam computed tomography system, head/neck

i-CAT FLX™ imaging system - D090083065000

V8
Dental Imaging Technologies Corporation
0.830.6500
In Commercial Distribution

08306500

  • Cone beam computed tomography system, head/neck

i-CAT FLX™ imaging system - D090083063000

V10
Dental Imaging Technologies Corporation
0.830.6300
In Commercial Distribution

08306300

  • Cone beam computed tomography system, head/neck

i-CAT FLX™ imaging system - D090083060000

V17
Dental Imaging Technologies Corporation
0.830.6000
In Commercial Distribution

08306000

  • Cone beam computed tomography system, head/neck

Biotres Pro - B635BIOTRESPR0

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOTRESPR0 ()


  • Electrocardiographic ambulatory recorder

Mediblu - B632MDB01042

HA12P
MEDIBLU MEDICAL LLC
HA12P
In Commercial Distribution

  • B632MDB01042 ()
MDB01042

  • Electrocardiographic ambulatory recorder

Mediblu - B632MDB01024

No Description
MEDIBLU MEDICAL LLC
HP50P
In Commercial Distribution

  • B632MDB01024 ()
MDB01024

  • Arrythmia-detection blood pressure ambulatory recorder

Mediblu - B632MDB01023

No Description
MEDIBLU MEDICAL LLC
HA3P
In Commercial Distribution

  • B632MDB01023 ()
MDB01023

  • Electrocardiographic ambulatory recorder

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

ProVecta 3D Prime Ceph - E247A78610

X-Ray System
DÜRR DENTAL SE
A7861
In Commercial Distribution

  • E247A78610 ()


  • Cone beam computed tomography system, head/neck
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