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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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NEO - 04035479184285

No Description
BIOTRONIK SE & Co. KG
2303.U
Not in Commercial Distribution

  • 04035479184285 ()
483001

  • Cardiac pulse generator programmer

PSW - 04035479182977

No Description
BIOTRONIK SE & Co. KG
2302.U
Not in Commercial Distribution

  • 04035479182977 ()
482011

  • Cardiac pulse generator programmer

PSW - 04035479181543

No Description
BIOTRONIK SE & Co. KG
2301.U
Not in Commercial Distribution

  • 04035479181543 ()
478650

  • Cardiac pulse generator programmer

NEO - 04035479179687

No Description
BIOTRONIK SE & Co. KG
2202.U
Not in Commercial Distribution

  • 04035479179687 ()
473587

  • Cardiac pulse generator programmer

NEO - 04035479179625

No Description
BIOTRONIK SE & Co. KG
2204.U
Not in Commercial Distribution

  • 04035479179625 ()
473540

  • Cardiac pulse generator programmer

NEO - 04035479178017

No Description
BIOTRONIK SE & Co. KG
2201.U/1
Not in Commercial Distribution

  • 04035479178017 ()
472133

  • Cardiac pulse generator programmer

Reference Plate Cover - 04953170077746

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-996
Not in Commercial Distribution

  • 04953170077746 ()


  • Sensor holder, reusable

NA - 04546540245038

UNIVERSAL TRACKER
Stryker Leibinger GmbH & Co. KG
6000-005-000
In Commercial Distribution

  • 04546540245038 ()
6000-005-000

  • Sensor holder, reusable

Medtronic CareLink® Programmer - 00613994127631

PROGRAMMER 2090W Tel C UPGRADE US
MEDTRONIC, INC.
2090W
Not in Commercial Distribution

  • 00613994127631 ()


  • Cardiac pulse generator programmer

NA - 00613994119995

WIRELESS ETHERNET 2091WB (802.11B) US MR
MEDTRONIC, INC.
2091WB
In Commercial Distribution

  • 00613994119995 ()


  • Cardiac pulse generator programmer

FUKUDA DENSHI - 04538612913792

No Description
FUKUDA DENSHI CO.,LTD.
FSD-8GA
In Commercial Distribution

  • 04538612913792 ()


  • Data storage card

FUKUDA DENSHI - 04538612913785

No Description
FUKUDA DENSHI CO.,LTD.
SD-16G
In Commercial Distribution

  • 04538612913785 ()


  • Data storage card

FUKUDA DENSHI - 04538612913778

No Description
FUKUDA DENSHI CO.,LTD.
FCS-64G
In Commercial Distribution

  • 04538612913778 ()


  • Data storage card

FUKUDA DENSHI - 04538612911231

No Description
FUKUDA DENSHI CO.,LTD.
FCF-16GA
In Commercial Distribution

  • 04538612911231 ()


  • Data storage card

FUKUDA DENSHI - 04538612911224

No Description
FUKUDA DENSHI CO.,LTD.
FCF-1000
In Commercial Distribution

  • 04538612911224 ()


  • Data storage card

FUKUDA DENSHI - 04538612911217

No Description
FUKUDA DENSHI CO.,LTD.
FCF-128
In Commercial Distribution

  • 04538612911217 ()


  • Data storage card

FUKUDA DENSHI - 04538612911200

No Description
FUKUDA DENSHI CO.,LTD.
SD-1G
In Commercial Distribution

  • 04538612911200 ()


  • Data storage card

FUKUDA DENSHI - 04538612910074

No Description
FUKUDA DENSHI CO.,LTD.
SD-8G
In Commercial Distribution

  • 04538612910074 ()


  • Data storage card

FUKUDA DENSHI - 04538612229992

No Description
FUKUDA DENSHI CO.,LTD.
FSD-32G
In Commercial Distribution

  • 04538612229992 ()


  • Data storage card

FUKUDA DENSHI - 04538612229800

No Description
FUKUDA DENSHI CO.,LTD.
FSD-64G
In Commercial Distribution

  • 04538612229800 ()


  • Data storage card

FUKUDA DENSHI - 04538612228698

No Description
FUKUDA DENSHI CO.,LTD.
SD-16G
In Commercial Distribution

  • 04538612228698 ()


  • Data storage card

FUKUDA DENSHI - 04538612100635

No Description
FUKUDA DENSHI CO.,LTD.
SD-2G
In Commercial Distribution

  • 04538612100635 ()


  • Data storage card

Medtronic CareLink® Programmer - 00613994434937

PROG 2090 TELC USA MKT EN EXT
MEDTRONIC, INC.
2090
Not in Commercial Distribution

  • 00613994434937 ()


  • Cardiac pulse generator programmer

NA - 00613994362896

RF Head 2067 10L 9FT Global
MEDTRONIC, INC.
2067
In Commercial Distribution

  • 00613994362896 ()

  • Length: 9.0 Feet


  • 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

Nonin - 00849686088151

7600PA Sensor Lock
NONIN MEDICAL, INC.
7600PA Sensor Lock
In Commercial Distribution

  • 00849686088151 ()


  • Sensor holder, reusable

Nonin - 00849686086188

7600PA Sensor Lock
NONIN MEDICAL, INC.
7600PA INT C Lock
In Commercial Distribution

  • 00849686086188 ()


  • Sensor holder, reusable

ANTENNA UNIT HOLDER - 04953170333330

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2034
In Commercial Distribution

  • 04953170333330 ()
N4472130

  • Sensor holder, reusable

RECEIVER DISH STAND SUPPLEMENTARY SET - 04953170305887

MAJ-1978 ScopeGuide RD Stand SET
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1978
Not in Commercial Distribution

  • 04953170305887 ()


  • Sensor holder, reusable

RECEIVER DISH ARM - 04953170305856

MAJ-1962 MAJ-1692 ScopeGuide Receiver Di
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1962
In Commercial Distribution

  • 04953170305856 ()


  • Sensor holder, reusable

HOLDER FOR HC-RP - 04953170305849

MAJ-1938 ScopeGuide Holder for HC-RC
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1938
In Commercial Distribution

  • 04953170305849 ()
  • 84953170305845 ()
N3807700

  • Sensor holder, reusable

RECEIVER DISH STAND - 04953170305771

MAJ-1907 ScopeGuide Receiver Dish Stand
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1907
In Commercial Distribution

  • 04953170305771 ()
N3807000

  • Sensor holder, reusable

Nucleus® SmartNav - 09321502065917

Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis 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® - 09321502050708

Nucleus® SmartNav
COCHLEAR LIMITED
P1652770
In Commercial Distribution

  • 09321502050708 ()
P1652770

  • Cochlear implant intraoperative electrophysiological analysis software

Hand adapter TOF3D - 04255629200430

No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
5750100
In Commercial Distribution

5750100

  • Sensor holder, reusable

NA - 04546540392091

INSTRUMENT TRACKER
Stryker Leibinger GmbH & Co. KG
6007-008-000
In Commercial Distribution

  • 04546540392091 ()
6007-008-000

  • Sensor holder, reusable

Volpara Live - 09421904268340

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
2.4
In Commercial Distribution

  • 09421904268340 ()


  • Radiological video camera patient positioning/tracking system software

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

Medtronic CareLink® Programmer - 00613994175403

PROG 2090 TEL C US EN SW JUN06
MEDTRONIC, INC.
2090
Not in Commercial Distribution

  • 00613994175403 ()


  • Cardiac pulse generator programmer
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