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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4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG10S1
In Commercial Distribution

  • 00842448114037 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG8R1
In Commercial Distribution

  • 00842448114006 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14S1
In Commercial Distribution

  • 00842448113993 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14R1
In Commercial Distribution

  • 00842448113986 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12S1
In Commercial Distribution

  • 00842448113979 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12R1
In Commercial Distribution

  • 00842448113962 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10S1
In Commercial Distribution

  • 00842448113955 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10R1
In Commercial Distribution

  • 00842448113948 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8S1
In Commercial Distribution

  • 00842448113931 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8R1
In Commercial Distribution

  • 00842448113924 ()


  • Dental implant system
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
reSET-O® Mobile Application running on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008118 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient’s substances of abuse during treatment, and - increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008088 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution

  • 00817491024268 ()
FG-5503-06-300

  • Implantable glucose monitoring system
Eversense CGM 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-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM 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-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM 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-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
DRUGS OF ABUSE 1
UTAK LABORATORIES, INC.
DA 1 WB VTS
In Commercial Distribution

  • B800DA1WBVTS5 ()
  • B800DA1WBVTS0 ()

  • Total Volume: 25 Milliliter
DA 1 WB VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZOYLECGONINE 1
UTAK LABORATORIES, INC.
BE M 1 VTS
In Commercial Distribution

  • B800BEM1VTS5 ()
  • B800BEM1VTS0 ()

  • Total Volume: 25 Milliliter
BE M 1 VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE PLUS
UTAK LABORATORIES, INC.
MOR+ U F VTS
In Commercial Distribution

  • B800MORUFVTS5 ()
  • B800MORUFVTS0 ()

  • Total Volume: 2 Milliliter
MOR+ U F VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system
No Description
Lonza Verviers
BESP1649Q
In Commercial Distribution

  • 05407010123968 ()
BESP1649Q

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
04-1167Q
In Commercial Distribution

  • 00840075402626 ()
04-1167Q

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
04-1150Q
In Commercial Distribution

  • 00840075401230 ()
04-1150Q

  • Ex vivo cell culture medium
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4004
In Commercial Distribution

  • D800BSFE4004 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4003
In Commercial Distribution

  • D800BSFE4003 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4002
In Commercial Distribution

  • D800BSFE4002 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4001
In Commercial Distribution

  • D800BSFE4001 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
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