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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SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer
SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000970079 ()


  • Multiple active implantable device programmer
SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • Multiple active implantable device programmer
SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • Multiple active implantable device programmer
SW APP A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • Multiple active implantable device programmer
SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution

  • 00763000371463 ()


  • Multiple active implantable device programmer
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
WAG Premium Arm GEN5 No Qualcomm/Homedics BT App
WALGREEN CO.
897652
In Commercial Distribution

  • 00311917206974 ()
  • 10311917206971 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SPRAY SET ENDOSCOPIC APP. 5MMX30 CM, 11:1 RATIO
Micromedics, Inc.
SA-3657
In Commercial Distribution

  • 00815634020177 ()
  • 10815634020174 ()
  • 20815634020171 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
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