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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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Optellum Virtual Nodule Clinic - B816VNC2P10

Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution

  • B816VNC2P10 ()
N/A

  • CT system application software

Medisoft - G407870A0

Treadmill 870 A
MEDISOFT RAM ITALIA SRL
870 A
In Commercial Distribution

  • G407870A0 ()
870 A

  • Cardiopulmonary stress exercise treadmill

UltraVision - B616UVTKL1440

Linear Ultrasonic Transducer
ULTRAVISION CORPORATION
Konica Linear Probe L14-4
In Commercial Distribution

  • B616UVTKL1440 ()
n/a

  • Extracorporeal ultrasound imaging transducer, hand-held

UltraVision - B616UVTKHL1840

Linear Ultrasonic Transducer
ULTRAVISION CORPORATION
Konica Hockey Stick Linear 18-4
In Commercial Distribution

  • B616UVTKHL1840 ()
n/a

  • Extracorporeal ultrasound imaging transducer, hand-held

UltraVision - B616UVTKCC520

Curved Ultrasonic Transducer
ULTRAVISION CORPORATION
Konica Curved Probe C5-2
In Commercial Distribution

  • B616UVTKCC520 ()
n/a

  • Extracorporeal ultrasound imaging transducer, hand-held

Higi White - B416SH650

The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
1301252105
In Commercial Distribution

  • B416SH650 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable

Higi Green (KMY) - B416KMY8202F0

The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
KMY-120630950-117
In Commercial Distribution

  • B416KMY8202F0 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable

JEDMED - M633512384A0

STYLET ONLY F/BRUENING NASAL SNARE
JEDMED INSTRUMENT COMPANY
51-2384 A
In Commercial Distribution

  • M633512384A0 ()
51-2384 A

  • Nasal snare, reusable

JEDMED - M633494313A0

ENT Endoscope 2.7MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4313 A
In Commercial Distribution

  • M633494313A0 ()
49-4313 A

  • Rigid optical sinoscope

JEDMED - M633494303A0

ENT Endoscope 4MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4303 A
In Commercial Distribution

  • M633494303A0 ()
49-4303 A

  • Rigid optical sinoscope
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