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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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Cycle Tracking 4.0 - 00194253312512

Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software

Cycle Tracking 3.0 - 00194252845974

Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software

Cycle Tracking 3.0 - 00194252845967

Cycle Tracking Watch App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845967 ()


  • Menstrual cycle self-monitoring software

Atrial Fibrillation History Feature - 00194252456804

Atrial Fibrillation History Feature Watch app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456804 ()


  • Self-care monitoring/reporting software

Atrial Fibrillation History Feature - 00194252456798

Atrial Fibrillation History Feature iPhone app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456798 ()


  • Self-care monitoring/reporting software

Halo Systems - 05690977308633

CB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500C
Not in Commercial Distribution

  • 05690977308633 ()
515500C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308626

CB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400C
Not in Commercial Distribution

  • 05690977308626 ()
515400C

  • Cervical spine immobilization head ring

N/A - 00643169771048

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

  • 00643169771048 ()


  • Infusion pump programmer

N/A - 00643169771031

SW APP A810 TDD CLINICIAN PROG
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00643169771031 ()


  • Infusion pump programmer

N/A - 00643169738065

SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer

Medline Industries, Inc. - 10080196992980

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

  • General surgical procedure kit, non-medicated, single-use

Medline - 10080196669943

PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator

Balloon applicator - 04953170355981

MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted

Reveal LINQ™ Mobile Manager - 00643169636651

SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software

Halo Systems - 05690977334960

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

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977326200

CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977319035

CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977308718

J TONG SML/MED- No App
OSSUR AMERICAS, INC.
JT-215
Not in Commercial Distribution

  • 05690977308718 ()
JT-215

  • Traction system skull tongs

Halo Systems - 05690977308664

OB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500D
Not in Commercial Distribution

  • 05690977308664 ()
515500D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308657

OB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400D
Not in Commercial Distribution

  • 05690977308657 ()
515400D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308640

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

  • 05690977308640 ()
515300D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308596

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

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring

OVY by Beurer - 00850003500560

Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser

N/A - 00643169855649

SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer

N/A - 00643169834330

SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer

N/A - 00643169834323

SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer

CareLink SmartSync™ PSA Application - 00643169833753

SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software

MEDLINE - 10193489194814

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

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit

Baha - 09321502036399

Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control

Baha - 09321502036382

Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
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