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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iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00012
Not in Commercial Distribution

  • 03615220002610 ()


  • Electroencephalographic monitoring system
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
TG Ab Ancillary Diluent - Atellica IM - CONS - 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995463
In Commercial Distribution

  • 00630414597904 ()
  • 00630414007304 ()
10995463

  • Buffered sample diluent IVD
4.8mm TG Hex Abutment Plastic Sleeve Hexed with Ti. Screw
TITAN IMPLANT INC
TN-48TGHAPSH
In Commercial Distribution

  • 00842448115621 ()


  • Dental implant suprastructure, temporary, preformed, single-use
T-CONNECT FOR SINGLE CROWN PREMIUM TG W H.4 MM
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-W-4
In Commercial Distribution

  • D7701220983 ()
A-TG-BASTZR-S-W-4

  • Dental implant suprastructure, permanent, preformed
T-CONNECT FOR SINGLE CROWN PREMIUM TG M H.4 MM
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M-4
In Commercial Distribution

  • D7701220953 ()
A-TG-BASTZR-S-M-4

  • Dental implant suprastructure, permanent, preformed
CAST. SLEEVE FOR 20GR ANGLED POST, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CC-MAPA-W
In Commercial Distribution

  • D7700884483 ()
A-TG-CC-MAPA-W

  • Dental implant suprastructure, permanent, preformed
CAST. SLEEVE FOR 20GR ANGLED POST, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CC-MAPA-M
In Commercial Distribution

  • D7700884473 ()
A-TG-CC-MAPA-M

  • Dental implant suprastructure, permanent, preformed
SPARE CASTABLE SLEEVE FOR GOLD BASE, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CCUC-W
In Commercial Distribution

  • D7700884273 ()
A-TG-CCUC-W

  • Dental implant suprastructure, permanent, preformed
SPARE CASTABLE SLEEVE FOR GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CCUC-M
In Commercial Distribution

  • D7700884263 ()
A-TG-CCUC-M

  • Dental implant suprastructure, permanent, preformed
CASTABLE REP. POST WITH GOLD BASE, PRE-KOH TG,WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-UCABU-W
In Commercial Distribution

  • D7700884233 ()
A-TG-UCABU-W

  • Dental implant suprastructure, permanent, preformed
CASTABLE REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-UCABU-M
In Commercial Distribution

  • D7700884223 ()
A-TG-UCABU-M

  • Dental implant suprastructure, permanent, preformed
CASTABLE REP. POST WITH GOLD BASE, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-UC-W
In Commercial Distribution

  • D7700884193 ()
A-TG-UC-W

  • Dental implant suprastructure, permanent, preformed
CASTABLE REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-UC-M
In Commercial Distribution

  • D7700884183 ()
A-TG-UC-M

  • Dental implant suprastructure, permanent, preformed
HAND DRIVER FOR REP. ABUTMENT PRE-KOH TG, MEDIUM/WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-AVVABUR
In Commercial Distribution

  • D7700884163 ()
A-TG-AVVABUR

  • Dental implant suprastructure, permanent, preformed
SIMPLE TEMP.POST TIT. INTERNAL PROF,NON REP, PREKOH TG WIDE
SWEDEN & MARTINA SPA
A-TG-MPST-W-ROT
In Commercial Distribution

  • D7700884113 ()
A-TG-MPST-W-ROT

  • Dental implant suprastructure, permanent, preformed
SIMPLE TEMP.POST TIT. INTERNAL PROF,NON REP, PREKOH TG MEDIUM
SWEDEN & MARTINA SPA
A-TG-MPST-M-ROT
In Commercial Distribution

  • D7700884103 ()
A-TG-MPST-M-ROT

  • Dental implant suprastructure, permanent, preformed
SIMPLE TEMP.POST TIT. INTERNAL PROF,REP, PREKOH TG WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-MPST-W
In Commercial Distribution

  • D7700884093 ()
A-TG-MPST-W

  • Dental implant suprastructure, permanent, preformed
OPEN TRAY TRANSF.FOR NON RIP. ABUT.,PRE-KOH TG,WIDE,MAGENTA
SWEDEN & MARTINA SPA
A-TG-TRABU-W-ROT
In Commercial Distribution

  • D7700880563 ()
A-TG-TRABU-W-ROT

  • Dental implant suprastructure, permanent, preformed
OPEN TRAY TRANSF.FOR NON RIP. ABUT.,PRE-KOH TG,MEDIUM,GREEN
SWEDEN & MARTINA SPA
A-TG-TRABU-M-ROT
In Commercial Distribution

  • D7700880553 ()
A-TG-TRABU-M-ROT

  • Dental implant suprastructure, permanent, preformed
CASTABLE CAP FOR PREMADE POSTS REP., PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPCM-W
In Commercial Distribution

  • D7700875013 ()
A-TG-CAPCM-W

  • Dental implant suprastructure, permanent, preformed
CASTABLE CAP FOR PREMADE POSTS REP., PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPCM-M
In Commercial Distribution

  • D7700875003 ()
A-TG-CAPCM-M

  • Dental implant suprastructure, permanent, preformed
SNAP ON CAP FOR CLOSED TRAY IMPRESSION, PRE-KOH TG, WIDE
SWEDEN & MARTINA SPA
A-TG-CAPIM-W
In Commercial Distribution

  • D7700874993 ()
A-TG-CAPIM-W

  • Dental implant suprastructure, permanent, preformed
SNAP ON CAP FOR CLOSED TRAY IMPRESSION, PRE-KOH TG, MEDIUM
SWEDEN & MARTINA SPA
A-TG-CAPIM-M
In Commercial Distribution

  • D7700874983 ()
A-TG-CAPIM-M

  • Dental implant suprastructure, permanent, preformed
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