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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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APP,KS CHOICE,4.0,IOS
Gn Hearing A/S
20993000
In Commercial Distribution

  • 05708296158409 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
Digital MDM (DMDM) Flowmeter + Bag Tee, Korea
PARKER-HANNIFIN CORPORATION
91525115 KOR
In Commercial Distribution

  • 00816711023937 ()
91525115 KOR

  • Oxygen/air/nitrous oxide breathing gas mixer
40151604 Digital MDM, 30%, Germany, Elbow Fittings
PARKER-HANNIFIN CORPORATION
91525187
In Commercial Distribution

  • 00816711023906 ()
91525187

  • Oxygen/air/nitrous oxide breathing gas mixer
40151602 Digital MDM, 30%, Germany, Straight Fittings
PARKER-HANNIFIN CORPORATION
91525178
In Commercial Distribution

  • 00816711023838 ()
91525178

  • Oxygen/air/nitrous oxide breathing gas mixer
FP ASM,10A,R,MDM,CIC,LP
Gn Hearing A/S
16086801
In Commercial Distribution

  • 05704819170286 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,L,MDM,CIC,LP
Gn Hearing A/S
16086701
In Commercial Distribution

  • 05704819170279 ()


  • Air-conduction hearing aid, canal
EAR GEL,VENT,WOE,MDM,BOX,6PCS
Gn Hearing A/S
22500400
In Commercial Distribution

  • 05708296260782 ()


  • Air-conduction hearing aid, in-the-ear
FP ASM,10A,R,MDM,CIC,HP
Gn Hearing A/S
15691801
In Commercial Distribution

  • 05708296050383 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,L,MDM,CIC,HP
Gn Hearing A/S
15691701
In Commercial Distribution

  • 05708296050369 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,R,MDM,CIC,LP
Gn Hearing A/S
15690801
In Commercial Distribution

  • 05708296050345 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,L,MDM,CIC,LP
Gn Hearing A/S
15690701
In Commercial Distribution

  • 05708296050321 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,R,MDM,CIC,HP
Gn Hearing A/S
16087001
In Commercial Distribution

  • 05708296019724 ()


  • Air-conduction hearing aid, canal
FP ASM,10A,L,MDM,CIC,HP
Gn Hearing A/S
16086901
In Commercial Distribution

  • 05708296019700 ()


  • Air-conduction hearing aid, canal
DOME,SF,OPEN,MDM,BAG,10 PCS
Gn Hearing A/S
19398300
In Commercial Distribution

  • 05708296067381 ()


  • Earmould, preformed
DOME,SF,PWR,MDM,BLSTR,8 PCS
Gn Hearing A/S
19399400
In Commercial Distribution

  • 05708296068999 ()


  • Earmould, preformed
DOME,SF,OPEN,MDM,BLSTR,8 PCS
Gn Hearing A/S
19399000
In Commercial Distribution

  • 05708296068951 ()


  • Earmould, preformed
DOME,THNTUB/REC,PWR,MDM,BAG,5
Gn Hearing A/S
18647300
In Commercial Distribution

  • 05708296068913 ()


  • Earmould, preformed
DOME,THNTUB/REC,SZ7,MDM,BAG,5
Gn Hearing A/S
18646900
In Commercial Distribution

  • 05708296068883 ()


  • Earmould, preformed
DOME,THNTUB/REC,SZ7,MDM,BAG,10
Gn Hearing A/S
18500900
In Commercial Distribution

  • 05708296067190 ()


  • Earmould, preformed
DOME,THNTUB/REC,PWR,MDM,BAG,10
Gn Hearing A/S
18265200
In Commercial Distribution

  • 05708296067176 ()


  • Earmould, preformed
DOME,REC,EXT,SZ7,MDM,BAG,10PCS
Gn Hearing A/S
18501600
In Commercial Distribution

  • 05708296140732 ()


  • Earmould, preformed
DOME,SF,PWR,MDM,BAG,10 PCS
Gn Hearing A/S
19398700
In Commercial Distribution

  • 05708296140039 ()


  • Earmould, preformed
DOME,SF,PWR,MDM,BAG,1 PCS
Gn Hearing A/S
21417100
In Commercial Distribution

  • 05708296191741 ()


  • Earmould, preformed
DOME,SF,OPEN,MDM,BAG,1 PCS
Gn Hearing A/S
21416700
In Commercial Distribution

  • 05708296191703 ()


  • Earmould, preformed
DOME,THNTUB/REC,SZ7,MDM,BAG,1
Gn Hearing A/S
21414500
In Commercial Distribution

  • 05708296191666 ()


  • Earmould, preformed
DOME,THNTUB/REC,PWR,MDM,BAG,1
Gn Hearing A/S
21414200
In Commercial Distribution

  • 05708296191635 ()


  • Earmould, preformed
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software
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