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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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Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP - 00817980020160

CB Series Analysis & Reporting S/W - 3 & 12 CH ECG & Combined ABPM
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020160 ()
A10-0036

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABP - 00817980020153

CB Series Analysis & Reporting S/W - 3 CH ECG & Combined ABPM
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020153 ()
A10-0035

  • Electrocardiographic long-term ambulatory recording analyser application software

Exactrac Robotics - 04056481006112

No Description
Brainlab AG
49702
Not in Commercial Distribution

  • 04056481006112 ()
49702

  • Therapeutic x-ray system table, powered

Robotics Oem - 04056481006105

No Description
Brainlab AG
49703
In Commercial Distribution

  • 04056481006105 ()
49703

  • Therapeutic x-ray system table, powered

AESCULAP - 04046955206858

SINGLE USE TEST CARD F/DUV 400
Aesculap AG
PV032SU
Not in Commercial Distribution

  • 04046955206858 ()
PV032SU

  • Surgical microscope filter

MARS - 00840682100069

MARS V8
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V8
Not in Commercial Distribution

  • 00840682100069 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

CellaVision DC-1 PPA - 07350040975107

No Description
Cellavision AB
XU-10302
In Commercial Distribution

  • 07350040975107 ()


  • Cell morphology analyser IVD, automated/semi-automated

CellaVision DC-1 - 07350040975091

No Description
Cellavision AB
XU-10301
In Commercial Distribution

  • 07350040975091 ()


  • Cell morphology analyser IVD, automated/semi-automated

CellaVision® DM9600 - 07350040974322

Automated cell locating device. DM9600 automatically locates and presents images of blood cells on peripherall blood smears.
Cellavision AB
XU-10288-01
In Commercial Distribution

  • 07350040974322 ()
XU-10288-01

  • Cell morphology analyser IVD, automated/semi-automated

Automated Digital Morphology Analyzer DI-60 - 07350040972021

Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears
Cellavision AB
CC286297
In Commercial Distribution

  • 07350040972021 ()
CC286297

  • Cell morphology analyser IVD, automated/semi-automated
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