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Hydroxylapatite (HA) coated push in dental implant 3.25 mm diameter x 10mm length
Simpler Implant Solutions Inc
S5002
In Commercial Distribution
- D780S50020 ()
- 3.25 millimeters diameter X 10 millimeter length
S5002
- Screw endosteal dental implant, two-piece
4.0mm Diameter x 8mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant
Simpler Implant Solutions Inc
S1 5005
In Commercial Distribution
- D780S150050 ()
- 3.25 millimeters diameter x 8mm length
S1 5005
- Screw endosteal dental implant, two-piece
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
Rescuer disposable CPR mask with one way valve in hard shell carrying case
B.L.S. Systems Limited
2025
In Commercial Distribution
- B002000CC0 ()
- B0022000CC8 ()
2025
- Cardiopulmonary resuscitation mask, single-use
The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-7 device is preloaded strands with Markers.
ISORAY MEDICAL, INC.
PL-7
Not in Commercial Distribution
- M748PL70 ()
- General-purpose brachytherapy system applicator, manual
Tween 20 is a detergent and an emulsifier used in wash buffers and other buffers for immunohistochemistry and in situ hybridization procedures. It can be used in autostainers, capillary action slides, as well as manual staining procedures.
BIO SB, INC.
100 ml
In Commercial Distribution
- B502BSB00450 ()
BSB 0045
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Tween 20 is a detergent and an emulsifier used in wash buffers and other buffers for immunohistochemistry and in situ hybridization procedures. It can be used in autostainers, capillary action slides, as well as manual staining procedures.
BIO SB, INC.
500 ml
In Commercial Distribution
- B502BSB00460 ()
BSB 0046
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
072MCV/072SCV - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.
072CBV/072CVV - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Clip with standard retention.
RHEIN 83 SRL
OT VERTICAL set
071OBV
- Dental implant suprastructure, permanent, preformed
Read-to-Use, Prostate Intraepithelial Neoplasia (PIN) kit is a multiplex triple color IHC Kit designed to detect prostate cancer in situ in the prostate glands.
BIO SB, INC.
Ready-to-use, 70 tests each
In Commercial Distribution
- B502BSB035270 ()
BSB 0352
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry