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Mazor X System
MAZOR ROBOTICS LTD
TPL0059-04
Not in Commercial Distribution
- 07290109180465 ()
TPL0059-04
- Multi-purpose stereotactic surgery system
PLASMABLADE X PS210-030S 3.0S GREEN
MEDTRONIC NAVIGATION, INC.
PS210-030S
In Commercial Distribution
- 00763000059811 ()
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS210-030S PINK
MEDTRONIC NAVIGATION, INC.
PS210-030S
In Commercial Distribution
- 00643169936683 ()
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
No Description
Poskom Co., Ltd.
Rextar X
In Commercial Distribution
- 08800040900047 ()
- Diagnostic x-ray system generator, portable
StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution
- B926SSSX10 ()
- CT system application software
Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be used with products of Nacera® Pearl (3Y-TZP).
DOCERAM medical ceramics GmbH
Blue X
Not in Commercial Distribution
- EDMC4000LQ80300 ()
- Weight: 15 Gram
4000LQ8030
- Dental appliance fabrication material, ceramic
No Description
H & O Equipments SA
CryoProbe|x
In Commercial Distribution
- B386SHOCXPRXX8010 ()
S-HO-CXPR-XX-801
- General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe|x+
In Commercial Distribution
- B386SHOCXPRP000 ()
S-HO-CXPRP-00
- General cryosurgical system, cryogen gas, mechanical
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution
- B761R60 ()
- Radiological PACS software
A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
SUNRISE MEDICAL (US) LLC
QS5 X
In Commercial Distribution
- 00016958059526 ()
EIF7
- Push-rim manual wheelchair, non-bariatric
Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution
- 03701313000479 ()
- Radiological PACS software
GlucoCare Intensive Glycemic Control System
Pronia Medical Systems Inc.
2.X
In Commercial Distribution
- G111GCR2 ()
- Clinical management support software
spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies.
ONEFIT MEDICAL
1.x
In Commercial Distribution
- 03700757200858 ()
- Orthopaedic/craniofacial implantation planning software
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
2.x
Not in Commercial Distribution
- 03700757200827 ()
/
- Orthopaedic/craniofacial implantation planning software
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
3.x
In Commercial Distribution
- 03700757200834 ()
- Orthopaedic/craniofacial implantation planning software
No Description
MILVUE
V1.1.x
In Commercial Distribution
- 03770024774047 ()
- Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839108 ()
- Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839092 ()
- Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution
- 03770020839085 ()
- Radiological PACS software
No Description
QYNAPSE
1.X
In Commercial Distribution
- 03770016198004 ()
- Radiology DICOM image processing application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202202OTC0 ()
- Medication reminder application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202201OTC0 ()
- Medication reminder application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. 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 blood pressure monitors, activity trackers, and weight scales as well as self reported health information. The software provides educational content to encourage behaviors which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining 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
In Commercial Distribution
- B553202195OTC0 ()
- Medication reminder application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. 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 blood pressure monitors, activity trackers, and weight scales as well as self reported health information. The software provides educational content to encourage behaviors which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining 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
In Commercial Distribution
- B553202194OTC0 ()
- Medication reminder application software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202193OTC0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202192OTC0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202191OTC0 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202175RX0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202174RX0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202173OTC0 ()
- Home pharmaceutical management support software