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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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No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software
CANISTER SUPPORT BRACKET TO ATTACH CANISTER DIRECTLY TO A VACUUM REGULATOR
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411001332 ()
  • 00704411001334 ()
443040415

  • General-purpose suction system, vacuum
No Description
BIOMET SPINE LLC
14-525110E
In Commercial Distribution

  • 00880304983014 ()

  • Double Set Screw Head to Head Cross-Connector
14-525110E

  • Bone-screw internal spinal fixation system, sterile
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