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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SYRINGE LABELER
BECTON, DICKINSON AND COMPANY
516800
In Commercial Distribution

  • 00382905168000 ()
516800

  • Intravenous injection automated detection/documentation system processor/transmitter
AMX Navigate Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
Navigate
In Commercial Distribution

  • 00195278003348 ()


  • Mobile basic diagnostic x-ray system, digital
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution

  • 10190302017756 ()


  • Human genomic analysis interpretive software
ODXTT UG & ADF V3.6 USB-US
LIFE TECHNOLOGIES CORPORATION
A49678
In Commercial Distribution

  • 10190302015646 ()


  • Human genomic analysis interpretive software
No Description
LIFE TECHNOLOGIES CORPORATION
A44913
In Commercial Distribution

  • 10190302015134 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A32441
In Commercial Distribution

  • 10190302015103 ()


  • Multiple tissue-associated protein/tumour marker IVD, reagent
No Description
LIFE TECHNOLOGIES CORPORATION
A38872
In Commercial Distribution

  • 10190302014335 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A32444
In Commercial Distribution

  • 10190302006156 ()


  • PCR/NAT negative control IVD
ONC DX TARGET DNA CONTROL
LIFE TECHNOLOGIES CORPORATION
A32442
In Commercial Distribution

  • 10190302006095 ()


  • Nucleic acid hybridization detection IVD, control
ODXTT UG AND ADF 1.8 - US
LIFE TECHNOLOGIES CORPORATION
A32461
In Commercial Distribution

  • 10190302006071 ()


  • Human genomic analysis interpretive software
No Description
LIFE TECHNOLOGIES CORPORATION
A32443
In Commercial Distribution

  • 10190302006064 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29362
In Commercial Distribution

  • 10190302005852 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29361
In Commercial Distribution

  • 10190302005845 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A30320
In Commercial Distribution

  • 10190302000888 ()


  • PCR/NAT negative control IVD
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000051 ()
MXU-RV71

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000044 ()
MXU-RV60

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000037 ()
MXU-RV35

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000013 ()
MXU-RV19

  • Mobile basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-32
In Commercial Distribution

  • 04540217060016 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-22
In Commercial Distribution

  • 04540217059980 ()


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

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital
XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Upgrade Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
NAVIGATE UPGRADE
In Commercial Distribution

  • 00195278798374 ()


  • Mobile basic diagnostic x-ray system, digital
Value Fixed Table
GE Hualun Medical Systems Co., Ltd
VFTBL-1
In Commercial Distribution

  • 00195278713766 ()
VFTBL-1

  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand
GE Hualun Medical Systems Co., Ltd
VMWS-1
In Commercial Distribution

  • 00195278713759 ()
VMWS-1

  • Stationary basic diagnostic x-ray system, digital
Definium Pace Select system designated medical device
GE Hualun Medical Systems Co., Ltd
Pace Select
In Commercial Distribution

  • 00195278526892 ()
B2604CAB

  • Stationary basic diagnostic x-ray system, digital
SCHICK33 CONVERSION 3.0 USB KIT, 9'
Dentsply International Inc.
100008721
In Commercial Distribution

  • D0031000087210 ()
100008721

  • Dental digital imaging sensor, intraoral
SCHICK33 CONVERSION 3.0 USB KIT, 6'
Dentsply International Inc.
100008720
In Commercial Distribution

  • D0031000087200 ()
100008720

  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR/AE CABLE FOR DSO 9FT
Dentsply International Inc.
100008665
In Commercial Distribution

  • D0031000086650 ()
100008665

  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR/AE CABLE FOR DSO 6FT
Dentsply International Inc.
100008664
In Commercial Distribution

  • D0031000086640 ()
100008664

  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/AE CABLE FOR DSO 9FT
Dentsply International Inc.
100008663
In Commercial Distribution

  • D0031000086630 ()
100008663

  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/AE CABLE FOR DSO 6FT
Dentsply International Inc.
100008662
In Commercial Distribution

  • D0031000086620 ()
100008662

  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR/AE CABLE FOR DSO 9FT
Dentsply International Inc.
100008661
In Commercial Distribution

  • D0031000086610 ()
100008661

  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR/AE CABLE FOR DSO 6FT
Dentsply International Inc.
100008660
In Commercial Distribution

  • D0031000086600 ()
100008660

  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR/3.0 CABLE RMA KIT 9'
Dentsply International Inc.
100008658
In Commercial Distribution

  • D0031000086580 ()
100008658

  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR/AE CABLE RMA KIT 6FT
Dentsply International Inc.
100008657
In Commercial Distribution

  • D0031000086570 ()
100008657

  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/3.0 CABLE RMA KIT 3FT
Dentsply International Inc.
100008656
In Commercial Distribution

  • D0031000086560 ()
100008656

  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/AE CABLE RMA KIT 9FT
Dentsply International Inc.
100008655
In Commercial Distribution

  • D0031000086550 ()
100008655

  • Dental digital imaging sensor, intraoral
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