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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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CareLink Encore™ - 00613994909565

PROGR HEAD 26901 ENCORE
MEDTRONIC, INC.
26901
In Commercial Distribution

  • 00613994909565 ()


  • Cardiac pulse generator programmer

Medtronic CareLink® Programmer - 00613994581594

PRGM 2090 USA EN OS MIGRATION UPGRADE
MEDTRONIC, INC.
2090
In Commercial Distribution

  • 00613994581594 ()


  • Cardiac pulse generator programmer

Medtronic CareLink® Programmer - 00613994581570

PRGM 2090 USA EN OS MIGRATION EXTENSION
MEDTRONIC, INC.
2090
In Commercial Distribution

  • 00613994581570 ()


  • Cardiac pulse generator programmer

NGENIUS - 04546540651563

NGENIUS UNIVERSAL TRACKER
Stryker Leibinger GmbH & Co. KG
6000-014-000
In Commercial Distribution

  • 04546540651563 ()
6000-014-000

  • Sensor holder, reusable

CareLink Encore™ - 00643169763548

PRGM 29901A ENCORE US EIFU
MEDTRONIC, INC.
29901A
In Commercial Distribution

  • 00643169763548 ()


  • Cardiac pulse generator programmer

IDENTIFY - EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software

Cochlear™ Objective Measures - 09321502070416

Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software

Nucleus® SmartNav - 09321502065917

Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software

Nucleus® - 09321502050708

Nucleus® SmartNav
COCHLEAR LIMITED
P1652770
In Commercial Distribution

  • 09321502050708 ()
P1652770

  • Cochlear implant intraoperative electrophysiological analysis software

Volpara Live - 09421904268340

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
2.4
In Commercial Distribution

  • 09421904268340 ()


  • Radiological video camera patient positioning/tracking system software
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