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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No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution

  • 00817491024268 ()
FG-5503-06-300

  • Implantable glucose monitoring system
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
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
Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
WAG Premium Arm GEN5 No Qualcomm/Homedics BT App
WALGREEN CO.
897652
In Commercial Distribution

  • 00311917206974 ()
  • 10311917206971 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
SPRAY SET ENDOSCOPIC APP. 5MMX40 CM, 11:1 RATIO
Micromedics, Inc.
SA-3658
In Commercial Distribution

  • 00815634020191 ()
  • 10815634020198 ()
  • 20815634020195 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
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
Tampons, Retail, App. Reg.25/Super 10/Super+ 10
Cora
02Tampons-322
In Commercial Distribution

  • 00850373007041 ()
  • 00810042481893 ()


  • Menstrual tampon, unscented
DBD-PUMP, APP W/PAD, AERO PULSE, 31" X 6
MEDLINE INDUSTRIES, INC.
MSC80700A
In Commercial Distribution

  • 30080196669886 ()
MSC80700A

  • Alternating-pressure inflator
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)
HERE WE FLO LTD
MEGA-AMZ-TAMP-1
In Commercial Distribution

  • 05060630101497 ()


  • Menstrual tampon, unscented
STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 NO LOGO
Oticon A/S
139346
In Commercial Distribution

  • 05707131268563 ()


  • Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 NO LOGO
Oticon A/S
139342
In Commercial Distribution

  • 05707131268549 ()


  • Hearing aid neck induction loop, wireless input
Med Aire Assure 5" Air + 3" Foam APP and LAL
Drive Devilbiss Healthcare
14530
In Commercial Distribution

  • 00822383536323 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
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