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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SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
Insertion Tool IOS Implant Replica Nobel Biocare N1™ NP/RP
Nobel Biocare AB
300966
In Commercial Distribution

  • 07332747162905 ()
300966

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

  • D7700884253 ()
A-TG-UCABU-W-ROT

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

  • D7700884243 ()
A-TG-UCABU-M-ROT

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

  • D7700884213 ()
A-TG-UC-W-ROT

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

  • D7700884203 ()
A-TG-UC-M-ROT

  • Dental implant suprastructure, permanent, preformed
15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-MAR15-W-60
In Commercial Distribution

  • D7700875783 ()
A-TG-MAR15-W-60

  • Dental implant suprastructure, permanent, preformed
15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-MAR15-M-60
In Commercial Distribution

  • D7700875773 ()
A-TG-MAR15-M-60

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H7 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-W-70
In Commercial Distribution

  • D7700874973 ()
A-TG-CAPGM-W-70

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H7 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-M-70
In Commercial Distribution

  • D7700874963 ()
A-TG-CAPGM-M-70

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H4 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-W-40
In Commercial Distribution

  • D7700874953 ()
A-TG-CAPGM-W-40

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H4 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-M-40
In Commercial Distribution

  • D7700874943 ()
A-TG-CAPGM-M-40

  • Dental implant suprastructure, permanent, preformed
OPEN TRAY TRANSFER SCREW M2 20 MM LONG, MAGENTA,PRE-KOH TG
SWEDEN & MARTINA SPA
A-TG-VTRA-200-20
In Commercial Distribution

  • D7700874693 ()
A-TG-VTRA-200-20

  • Dental implant suprastructure, permanent, preformed
OPEN TRAY TRANSFER SCREW M1.8 20 MM LONG, GREEN, PRE-KOH TG
SWEDEN & MARTINA SPA
A-TG-VTRA-180-20
In Commercial Distribution

  • D7700874683 ()
A-TG-VTRA-180-20

  • Dental implant suprastructure, permanent, preformed
Vial Adapter 20mm FLL TG w/15 mic m Filter - VF
WEST PHARMA. SERVICES IL, . LTD
8072120
Not in Commercial Distribution

  • 27290108240270 ()
  • 17290108240273 ()
  • 37290108240277 ()
  • 07290108240276 ()


  • Vial/bottle adaptor, non-hermetic
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.2.1
In Commercial Distribution

  • 04250903201202 ()
2067634-056

  • Electrocardiographic ambulatory recorder
The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution

  • 08051122040964 ()
SPM01K3

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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