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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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MEPHYSTO - EPTWS0800450

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MEPHYSTO mc² software
In Commercial Distribution

  • EPTWS0800450 ()
S080045

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700230

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
IsoCheck epid software
In Commercial Distribution

  • EPTWS0700230 ()
S070023

  • Multi-modality therapeutic radiation phantom, anthropomorphic

MLCSoft - EPTWS0700220

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MLCSoft epid software
In Commercial Distribution

  • EPTWS0700220 ()
S070022

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0300060

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaControl Expert software
In Commercial Distribution

  • EPTWS0300060 ()
S030006

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - 10886982007407

EX NAIL POWER ADAPTER
SYNTHES (U.S.A.) LP
SD516.324
Not in Commercial Distribution

  • H679SD5163240 ()
  • 10886982007407 ()
SD516324

  • Multi-purpose surgical power tool system, rechargeable battery-powered

HUMA - G2871002

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution

  • G2871002 ()
1002

  • Self-care monitoring/reporting software

Exer Scan - G186EXERSCAN20

No Description
Exer Labs, Inc.
2
In Commercial Distribution

  • G186EXERSCAN20 ()


  • Self-care monitoring/reporting software

Exer Physio - G186EXERPHYSIO20

No Description
Exer Labs, Inc.
2
In Commercial Distribution

  • G186EXERPHYSIO20 ()


  • Self-care monitoring/reporting software

Exer Health - G186EXERHEALTH20

No Description
Exer Labs, Inc.
2
In Commercial Distribution

  • G186EXERHEALTH20 ()


  • Self-care monitoring/reporting software

Levo - G172616890

No Description
Levo Medical Corporation
Manager
In Commercial Distribution

61689

  • Tinnitus masking application software
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