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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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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 - 04538612228698

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

  • 04538612228698 ()


  • Data storage card

FUKUDA DENSHI - 04538612911231

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

  • 04538612911231 ()


  • 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 - 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

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

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

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

RECEIVER DISH ARM - 04953170305856

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

  • 04953170305856 ()


  • 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

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

Reference Plate Cover - 04953170077746

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

  • 04953170077746 ()


  • Sensor holder, reusable

ON-Q* Pain Relief System with SOAKER* Catheter - 00193494000134

No Description
Avanos Medical, Inc.
PS6506-N
In Commercial Distribution

  • 10193494000131 ()
  • 00193494000134 ()
PS6506-N

  • Cardiac pulse generator programmer

Nonin - 00833166009262

Lanyard
NONIN MEDICAL, INC.
Lanyard. GO2
In Commercial Distribution

  • 00833166009262 ()
  • 00833166006049 ()


  • Sensor holder, reusable

Nonin - 00833166007206

Lanyard & lock
NONIN MEDICAL, INC.
9500
In Commercial Distribution

  • 00833166007206 ()
  • 00833166007107 ()


  • Sensor holder, reusable

Nonin - 00833166001303

Wrist Strap
NONIN MEDICAL, INC.
3150
In Commercial Distribution

  • 00833166009927 ()
  • 00833166001303 ()


  • Sensor holder, reusable

Nonin - 00833166000818

Toe Wrap
NONIN MEDICAL, INC.
8000TW
In Commercial Distribution

  • 00833166000818 ()
  • 00849686066234 ()

  • Pediatric
  • Adult


  • Sensor holder, reusable

Nonin - 00833166000795

Finger Wrap
NONIN MEDICAL, INC.
8000FW
In Commercial Distribution

  • 00833166000795 ()

  • Pediatric
  • Adult


  • Sensor holder, reusable

ROSA® Arm Reference Frame - 00889024505254

No Description
Orthosoft Inc
20-8020-015-00
In Commercial Distribution

  • 00889024505254 ()
20-8020-015-00

  • Sensor holder, reusable

ROSA® Base Reference Frame - 00889024505148

No Description
Orthosoft Inc
20-8020-002-00
In Commercial Distribution

  • 00889024505148 ()
20-8020-002-00

  • Sensor holder, reusable

CPR4 - 08031527019611

Inductive Telemetry Head CPR4 USB
MICROPORT CRM SRL
B10031
In Commercial Distribution

  • 08031527019611 ()
B10031

  • Cardiac pulse generator programmer

Smartview - 08031527017174

No Description
MICROPORT CRM SRL
2.56
In Commercial Distribution

  • 08031527017174 ()


  • Cardiac pulse generator programmer

SMARTVIEW - 08031527016788

No Description
MICROPORT CRM SRL
2.52 UG1
In Commercial Distribution

  • 08031527016788 ()


  • Cardiac pulse generator programmer

SMARTVIEW - 08031527016375

No Description
MICROPORT CRM SRL
2.50 UG1
In Commercial Distribution

  • 08031527016375 ()


  • Cardiac pulse generator programmer

Smartview - 08031527014487

No Description
MICROPORT CRM SRL
2.42UG1
In Commercial Distribution

  • 08031527014487 ()


  • Cardiac pulse generator programmer

ORCHESTRA PLUS LINK - 08031527014210

No Description
MICROPORT CRM SRL
None
In Commercial Distribution

  • 08031527014210 ()


  • Cardiac pulse generator programmer

Smartview - 08031527013886

No Description
MICROPORT CRM SRL
2.40UG1
In Commercial Distribution

  • 08031527013886 ()


  • Cardiac pulse generator programmer

Orchestra - 08031527013367

No Description
MICROPORT CRM SRL
Plus
In Commercial Distribution

  • 08031527013367 ()


  • Cardiac pulse generator programmer

CPR3 - 08031527013350

No Description
MICROPORT CRM SRL
CPR3
In Commercial Distribution

  • 08031527013350 ()


  • Cardiac pulse generator programmer

SmartView - 08031527021089

SmartView 3.14 UG1 (US)
MICROPORT CRM SRL
SmartView 3.14
In Commercial Distribution

  • 08031527021089 ()
SmartView 3.14

  • Cardiac pulse generator programmer

PSW - 04035479166397

No Description
BIOTRONIK SE & Co. KG
1904.U
Not in Commercial Distribution

  • 04035479166397 ()
448682

  • Cardiac pulse generator programmer

PSW - 04035479164423

No Description
BIOTRONIK SE & Co. KG
1901.U
Not in Commercial Distribution

  • 04035479164423 ()
445665

  • Cardiac pulse generator programmer

PSW - 04035479164416

No Description
BIOTRONIK SE & Co. KG
1804.U
Not in Commercial Distribution

  • 04035479164416 ()
445664

  • Cardiac pulse generator programmer

Renamic Neo - 04035479163068

No Description
BIOTRONIK SE & Co. KG
424723
In Commercial Distribution

  • 04035479163068 ()
424723

  • Cardiac pulse generator programmer

PSW - 04035479162047

No Description
BIOTRONIK SE & Co. KG
1802.U
Not in Commercial Distribution

  • 04035479162047 ()
443620

  • Cardiac pulse generator programmer

PSW - 04035479160838

No Description
BIOTRONIK SE & Co. KG
1801.U
Not in Commercial Distribution

  • 04035479160838 ()
440931

  • Cardiac pulse generator programmer

PSW - 04035479157708

No Description
BIOTRONIK SE & Co. KG
1704.U
Not in Commercial Distribution

  • 04035479157708 ()
431889

  • Cardiac pulse generator programmer

PSW - 04035479157692

No Description
BIOTRONIK SE & Co. KG
1703.U
Not in Commercial Distribution

  • 04035479157692 ()
431888

  • Cardiac pulse generator programmer

PSW - 04035479157678

No Description
BIOTRONIK SE & Co. KG
1702.U
Not in Commercial Distribution

  • 04035479157678 ()
431886

  • Cardiac pulse generator programmer

PSW - 04035479150211

No Description
BIOTRONIK SE & Co. KG
1503.U
Not in Commercial Distribution

  • 04035479150211 ()
411917

  • Cardiac pulse generator programmer

PSW - 04035479150204

No Description
BIOTRONIK SE & Co. KG
1502.U
Not in Commercial Distribution

  • 04035479150204 ()
411916

  • Cardiac pulse generator programmer
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