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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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Complete Blood Pressure Monitor +EKG - 00073796267902

Blood Pressure Monitor and single channel EKG device.
Omron Healthcare, Inc.
BP7900
In Commercial Distribution

  • 10073796267909 ()
  • 00073796267902 ()
BP7900

  • Multiple vital physiological parameter monitoring system, home-use

Smart-V-Link - 00894912002777

Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software

THD Procto Software System - 08033737713037

The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - Endoanal ultrasound (trans-rectal ultrasound / echography) - Anoscopy exams - Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution

  • 08033737713037 ()
760004

  • Ultrasound imaging system application software

AIDA compact - 04048551342855

KARL STORZ AIDA control
Karl Storz GmbH & Co. KG
20096020
In Commercial Distribution

  • 04048551342855 ()


  • Physician-practice-management information system

Augmented Reality Application - G67910

No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system

Cardiac Function Laboratory - 08717953256645

Inca PV loop system for the measurement of cardiac function and performance.
CD Leycom
CFL-M Inca
In Commercial Distribution

  • 08717953256645 ()
CDL001

  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729966326

Ablation Connection Box (Maestro™)
BOSTON SCIENTIFIC CORPORATION
M004RA6201US0
In Commercial Distribution

  • 08714729966326 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729960096

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBEVAL2END0
In Commercial Distribution

  • 08714729960096 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948407

Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40100
In Commercial Distribution

  • 08714729948407 ()
M004RH40100

  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948377

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14510
In Commercial Distribution

  • 08714729948377 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948360

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14010
In Commercial Distribution

  • 08714729948360 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948322

Breakout Box
BOSTON SCIENTIFIC CORPORATION
M004RH11020
In Commercial Distribution

  • 08714729948322 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729938682

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2EN0
In Commercial Distribution

  • 08714729938682 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729907060

IntellaNav™ CB - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62500
In Commercial Distribution

  • 08714729907060 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729905899

ECG Out Box and Cable Kit 1 US
BOSTON SCIENTIFIC CORPORATION
M004RB5000US0
In Commercial Distribution

  • 08714729905899 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729863199

Rhythmia Global Install Bundle
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL10
In Commercial Distribution

  • 08714729863199 ()


  • Cardiac mapping system

Playbook - 00840194471954

Playbook Assembly
ORTHOPEDIATRICS CORP.
01-4200-0001
Not in Commercial Distribution

  • 00840194471954 ()
01-4200-0001

  • Medical image management system

Playbook - 00840194493765

Assembled Playbook Unit
ORTHOPEDIATRICS CORP.
NS-4200-0001
In Commercial Distribution

  • 00840194493765 ()
NS-4200-0001

  • Medical image management system

Quantib ND - 08719689791261

No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791261 ()


  • MRI system application software

Quantib Brain - 08719689791254

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software

Quantib ND - 08719689791216

No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software

Quantib ND - 08719689791179

No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software

Quantib ND - 08719689791148

No Description
Quantib B.V.
1.8
In Commercial Distribution

  • 08719689791148 ()


  • MRI system application software

Quantib ND - 08719689791094

No Description
Quantib B.V.
1.7
In Commercial Distribution

  • 08719689791094 ()


  • MRI system application software

Quantib Brain - 08719689791070

No Description
Quantib B.V.
1.4
In Commercial Distribution

  • 08719689791070 ()


  • MRI system application software

Quantib ND - 08719689791032

No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software

Quantib ND - 08719689791001

No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791001 ()


  • MRI system application software

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system
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