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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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reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera
B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
ENDOTEC, INC.
04-32-0462
Not in Commercial Distribution

  • 00814193021519 ()

  • SIZE 2, TYPE 0
04-32-0462

  • Cruciate-retaining total knee prosthesis
ENHANCED ALGORITHM ECG EVENT RECORDER https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
BRAEMAR MANUFACTURING, LLC
900-0557-01
In Commercial Distribution

  • B146ER9B0 ()


  • Electrocardiography telemetric monitoring system
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
LAP-Instrument, Ø10mm, l=450mm, detach. Grasping forceps TENACULUM, d/a Stainl.steel handle, insul., w/o ratchethttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DANNORITZER Medizintechnik GmbH & Co. KG
LMC-148-345
Not in Commercial Distribution

  • 04251351105326 ()
LMC-148-345

  • Rigid endoscopic tissue manipulation forceps, reusable
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution

  • B553202058OTC0 ()


  • Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution

  • B553202057OTC0 ()


  • Self-care monitoring/reporting software
No Description
CHURCH & DWIGHT CO., INC.
00022600019558
In Commercial Distribution

  • 00022600019558 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution

  • B553202258OTC0 ()


  • Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution

  • B553202257OTC0 ()


  • Self-care monitoring/reporting software
Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
CLINICAL INNOVATIONS, LLC
PRS-0530
In Commercial Distribution

  • 30814247020346 ()
  • 40814247020343 ()


  • Abdominal retractor, hand-held
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-A
In Commercial Distribution

  • 05060396173127 ()


  • Evoked-potential audiometer
OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-D
In Commercial Distribution

  • 05060396173110 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-T
In Commercial Distribution

  • 05060396173103 ()


  • Otoacoustic emission system, battery-powered
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI5.000.05
Not in Commercial Distribution

  • ENTTUTG10MI5000051 ()

  • Diameter: Ø 5,0 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI5.000.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DA
In Commercial Distribution

  • 05060396173721 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-D
In Commercial Distribution

  • 05060396173714 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DT
In Commercial Distribution

  • 05060396173486 ()


  • Otoacoustic emission system, battery-powered
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer
ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
ORGENTEC Diagnostika GmbH
ORG502
Not in Commercial Distribution

  • 04260157080010 ()
ORG502

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI3.342.05
Not in Commercial Distribution

  • ENTTUTG10MI3342051 ()

  • Diameter: Ø 3,3 - 4,25 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI3.342.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DTA
In Commercial Distribution

  • 05060396173172 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DA
In Commercial Distribution

  • 05060396173158 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-TA
In Commercial Distribution

  • 05060396173141 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002M
Not in Commercial Distribution

  • ENTTUTG2CON8050002M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001M
Not in Commercial Distribution

  • ENTTUTG2CON8050001M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution

  • 05060396173165 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002S
Not in Commercial Distribution

  • ENTTUTG2CON8050002S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001S
Not in Commercial Distribution

  • ENTTUTG2CON8050001S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422M
Not in Commercial Distribution

  • ENTTUTG2CON8033422M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421M
Not in Commercial Distribution

  • ENTTUTG2CON8033421M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
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