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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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
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
Wireless Endoscopic Camera System with Wifi, 1080p, Endovision App, White
MARINA MEDICAL INSTRUMENTS, INC.
350-525
In Commercial Distribution

  • 00840306836374 ()
350-525

  • Endoscope video camera
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
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
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