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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Reverse Lip ASA Rigid 32x80mm - SL
THOMPSON SURGICAL INSTRUMENTS, INC.
6300
In Commercial Distribution

  • 00841536138344 ()


  • Surgical retraction system, reusable
No Description
CARDICARE COMPANY LTD
AS-MC+SR KIT
In Commercial Distribution

  • 26970366970065 ()
  • 06970366970061 ()


  • Aneroid manual sphygmomanometer
No Description
CARDICARE COMPANY LTD
AS-MC-TH
In Commercial Distribution

  • 26970366970058 ()
  • 06970366970054 ()


  • Aneroid manual sphygmomanometer
No Description
CARDICARE COMPANY LTD
AS-MC-OB
In Commercial Distribution

  • 26970366970041 ()
  • 06970366970047 ()


  • Aneroid manual sphygmomanometer
No Description
CARDICARE COMPANY LTD
AS-MC-PED
In Commercial Distribution

  • 26970366970034 ()
  • 06970366970030 ()


  • Aneroid manual sphygmomanometer
Aneroid Sphygmomanometer
CARDICARE COMPANY LTD
AS-MC
In Commercial Distribution

  • 26970366970010 ()
  • 06970366970016 ()


  • Aneroid manual sphygmomanometer
SnugFit ASA Size1 USP#2/Tape (bl+w/bk) Long
Medacta International SA
05.11.083
In Commercial Distribution

  • 07630542778988 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 USP#2/Tape (bl+w/bk) Short
Medacta International SA
05.11.082
In Commercial Distribution

  • 07630542778971 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 USP#2/Tape (bl+w/bl) Long
Medacta International SA
05.11.081
In Commercial Distribution

  • 07630542778964 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 USP#2/Tape (bl+w/bl) Short
Medacta International SA
05.11.080
In Commercial Distribution

  • 07630542778957 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xTape (bl+w/bk) Long
Medacta International SA
05.11.079
In Commercial Distribution

  • 07630542778940 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xTape (bl+w/bk) Short
Medacta International SA
05.11.078
In Commercial Distribution

  • 07630542778933 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xTape (bl+w/bl) Long
Medacta International SA
05.11.077
In Commercial Distribution

  • 07630542778926 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xTape (bl+w/bl) Short
Medacta International SA
05.11.076
In Commercial Distribution

  • 07630542778919 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xUSP#2 (bl+w/bk) Long
Medacta International SA
05.11.075
In Commercial Distribution

  • 07630542778902 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xUSP#2 (bl+w/bk) Short
Medacta International SA
05.11.074
In Commercial Distribution

  • 07630542778896 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xUSP#2 (bl+w/bl) Long
Medacta International SA
05.11.073
In Commercial Distribution

  • 07630542778889 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 2xUSP#2 (bl+w/bl) Short
Medacta International SA
05.11.072
In Commercial Distribution

  • 07630542778872 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit All-Suture Anchor Size2 3xUSP#2 loop Short
Medacta International SA
05.11.036
In Commercial Distribution

  • 07630542771446 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit All-Suture Anchor Size2 Tape2.2/USP2 Short
Medacta International SA
05.11.035
In Commercial Distribution

  • 07630542771439 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit All-Suture Anchor Size2 3xTape Short
Medacta International SA
05.11.034
In Commercial Distribution

  • 07630542771422 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit All-Suture Anchor Size2 USP#2/2xTape Short
Medacta International SA
05.11.033
In Commercial Distribution

  • 07630542771415 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
ASA (anti-skin) Monkey Esophagus 96 Test Kit
SCIMEDX CORPORATION
6001-96-ES
In Commercial Distribution

  • 00813545027131 ()
6001-96-ES

  • Skin antibody IVD, kit, fluorescent immunoassay
ASA (anti-skin) Monkey Esophagus 48 Test Kit
SCIMEDX CORPORATION
6001-48-ES
In Commercial Distribution

  • 00813545027124 ()
6001-48-ES

  • Skin antibody IVD, kit, fluorescent immunoassay
Reverse Lip ASA Tapered 25 x 102mm
THOMPSON SURGICAL INSTRUMENTS, INC.
46194TE
In Commercial Distribution

  • 00841536116182 ()


  • Surgical retraction system, reusable
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control
APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control
APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control
APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control
Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software
Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software
iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software
myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software
Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer
myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
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