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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APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control
STRL ALLENTWN LAP CHOLE APP PK
Cardinal Health 200, LLC
SLC11LLSLG
In Commercial Distribution

  • 50885425518300 ()
  • 10885425518302 ()
SLC11LLSLG

  • Laparoscopic surgical procedure kit, non-medicated, single-use
DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay system
DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system
APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
SCS Remote App (compatible with Android)
NALU MEDICAL, INC.
53002-001
In Commercial Distribution

  • 00812537030470 ()
53002-001

  • Implantable electrical stimulation device management software
LAMP Words For Life (US) App
PRENTKE ROMICH COMPANY
LAMP WFL App
In Commercial Distribution

  • 00816486021084 ()
16659

  • Voice synthesizer/digitizer
LAMP Words For Life (UK) App
PRENTKE ROMICH COMPANY
LAMP WFL (UK) App
In Commercial Distribution

  • 00816486021077 ()
16659-2

  • Voice synthesizer/digitizer
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2591
In Commercial Distribution

  • 00653160360462 ()
  • 10653160360469 ()
DYNDV2591

  • Peripheral intravenous catheterization support kit
IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571
In Commercial Distribution

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • Peripheral intravenous catheterization support kit
IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571A
In Commercial Distribution

  • 00653160373646 ()
  • 10653160373643 ()
DYNDV2571A

  • Peripheral intravenous catheterization support kit
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
Cycle Tracking iPhone App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312529 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software
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