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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CB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300C
Not in Commercial Distribution

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring
SW APP A820 TDD PATIENT PROG
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00643169771048 ()


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

  • 00643169771031 ()


  • Infusion pump programmer
SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer
FreeStyle Libre 3 Android App US
ABBOTT DIABETES CARE INC
72075-01
In Commercial Distribution

  • 00357599816001 ()
72075-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 App Android US
ABBOTT DIABETES CARE INC
71857-01
In Commercial Distribution

  • 00357599809003 ()
71857-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2325
In Commercial Distribution

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit
PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

  • General surgical procedure kit, non-medicated, single-use
Bone Graft App Plugger & Scoop, Z-Line
Karl Schumacher Dental, LLC
SPA1422
In Commercial Distribution

  • 00842517117266 ()


  • Periosteal elevator, reusable
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software
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
Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software
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