SEARCH RESULTS FOR: 旺财超级签折扣常见安全问题-电报@Qianmingipa8‼️贷款app企业签名.lyz(3572 results)
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
No Description
AMMEX CORPORATION
1ENVPFXLCS2
In Commercial Distribution
- 10819856020486 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFLCS2
In Commercial Distribution
- 10819856020479 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFMCS2
In Commercial Distribution
- 10819856020462 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFSCS2
In Commercial Distribution
- 10819856020455 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFXLBX2
In Commercial Distribution
- 00819856022490 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFLBX2
In Commercial Distribution
- 00819856022483 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFMBX2
In Commercial Distribution
- 00819856022476 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
No Description
AMMEX CORPORATION
1ENVPFSBX2
In Commercial Distribution
- 00819856022469 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Vinyl examination/treatment glove, non-powdered
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
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
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