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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
ergoline GmbH
161801
In Commercial Distribution

  • 04059358001838 ()


  • Cardiopulmonary parameter spot-check measurement software
CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment)
NovaSight Inc
CS 100
In Commercial Distribution

  • 00199284316898 ()


  • Dynamic visual acuity testing system
MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation software
No Description
Wellysis Corp.
0
In Commercial Distribution

  • 08800159500022 ()


  • Telemetric electrocardiographic ambulatory recorder
No Description
Wellysis Corp.
0
In Commercial Distribution

  • 08800159500015 ()


  • Telemetric electrocardiographic ambulatory recorder
MAXFRAME(TM) 2.0 SOFTWARE
Synthes GmbH
03.312.002
In Commercial Distribution

  • 07612334226563 ()
  • 10886982308641 ()
03312002

  • External orthopaedic fixation frame calculation software
MAXFRAME AUTOSTRUT (TM) SOFTWARE
Synthes GmbH
03.312.003
In Commercial Distribution

  • 10886982346896 ()
03312003

  • External orthopaedic fixation frame calculation software
MAXFRAME AUTOSTRUT(TM) SOFTWARE
SYNTHES (U.S.A.) LP
1110005-01
In Commercial Distribution

  • 10886982340832 ()
111000501

  • External orthopaedic fixation frame calculation software
No Description
BIOTRONIK SE & Co. KG
435292
In Commercial Distribution

  • 04035479158330 ()
435292

  • Implantable cardiac monitor programmer/transmitter/alarm
No Description
BIOTRONIK SE & Co. KG
Remote Assistant
Not in Commercial Distribution

  • 04035479144227 ()
405475

  • Implantable cardiac monitor programmer/transmitter/alarm
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