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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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SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software
SW D00U004 SS PERCEPTA SERENA SOLERA
MEDTRONIC, INC.
D00U004
In Commercial Distribution

  • 00763000002046 ()


  • Implantable cardiac device management application software
SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
D00U003
In Commercial Distribution

  • 00763000002039 ()


  • Implantable cardiac device management application software
SW CLN CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN
In Commercial Distribution

  • 00763000017347 ()


  • Implantable cardiac device management application software
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution

  • 07640167751242 ()
410.030.007

  • Optical low coherence reflectometry (OLCR) biometer
  • Eye anterior segment analyser
  • Corneal topography system application software
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
iFusion 80 with 12 MP Camera
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006766 ()
700-54542-001

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006650 ()
700-49003-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
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