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proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at office and required to be used in a quiet environment. This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution
- 00860006184926 ()
- Home uroflowmetry software
proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function.
This device can be used at home and required to be used in a quiet environment.
This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution
- 00860006184902 ()
- Home uroflowmetry software
No Description
Tmr Orthopedics, LLC
TMR 001-6.5-120
In Commercial Distribution
- 00860006173302 ()
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution
- 00860006172008 ()
01-0001-001
- Mindfulness/behavioural therapy software, non-clinician-consultative
SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Premium Natural Cosmetics Inc.
00860006114107
In Commercial Distribution
- 00860006114107 ()
- Sexual lubricant
Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution
- 00860005970209 ()
60005-97020
- Mindfulness/behavioural therapy software, non-clinician-consultative
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure.
The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm.
There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire.
Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution
- 00860005968800 ()
- Orthopaedic bone screw, non-bioabsorbable, sterile
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
SeeFactorCT3
Not in Commercial Distribution
- 00860005941605 ()
860005941605
- Cone beam computed tomography system, head/neck
No Description
Adam Lawrence
TD-4279
In Commercial Distribution
- 00860005745944 ()
- Multiple clinical chemistry analyte monitoring system IVD, home-use
No Description
Adam Lawrence
TD-4279
In Commercial Distribution
- 00860005745906 ()
- Ketone (acetoacetate) IVD, reagent