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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 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
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution
- 00860006137014 ()
- Medical networking interface unit
eClinics is a stand-alone software product used by professional care providers in ICU and other critical care settings for the presentation, collection, management and storage of patient information
Ceiba Healthcare Technologies LLC
eClinics
In Commercial Distribution
- 00860006137007 ()
- Medical equipment clinical data interfacing software
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
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 32MM - # 7732-30
In Commercial Distribution
- 00860006105099 ()
- 00860006105075 ()
- Urinary incontinence penis sheath/port, single-use
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 29MM - # 7729-30
In Commercial Distribution
- 00860006105051 ()
- 00860006105037 ()
- Urinary incontinence penis sheath/port, single-use
VR Thumb Loop Gown, Large 4 Mil Green, Case - 50 Ct.
POLYCONVERSIONS, INC.
42506
In Commercial Distribution
- 00860006079192 ()
- Surgical/examination garment kit
VR Thumb Loop Gown, Large 4 Mil Green
POLYCONVERSIONS, INC.
42506
In Commercial Distribution
- 00860006079185 ()
- Surgical/examination garment kit
VR Thumb Loop Gown, Regular 4 Mil Green
POLYCONVERSIONS, INC.
42406
In Commercial Distribution
- 00860006079178 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Extra Small Green Unlined
POLYCONVERSIONS, INC.
41260
In Commercial Distribution
- 00860006079147 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Small Green Unlined
POLYCONVERSIONS, INC.
41360
In Commercial Distribution
- 00860006079130 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Medium Green Unlined
POLYCONVERSIONS, INC.
41460
In Commercial Distribution
- 00860006079123 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Large Green Unlined
POLYCONVERSIONS, INC.
41560
In Commercial Distribution
- 00860006079116 ()
- Surgical/examination garment kit
Sleeve Gloves 15 Mil Extra Large Green Unlined
POLYCONVERSIONS, INC.
41660
In Commercial Distribution
- 00860006079109 ()
- Surgical/examination garment kit
Cervical spinal stenosis curette
Neuro Enterprises, LLC
NE5
In Commercial Distribution
- 00860006017736 ()
- Neurosurgical curette, single-use
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
Bartels FlexTrans Transport Medium 3mL Tube 1800pcs
KEYSTONE MANUFACTURING, LLC
KMVIAL-VTM3ML-1800
In Commercial Distribution
- 00860005748327 ()
- General tissue specimen container IVD, fixative/saline
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM05-100
In Commercial Distribution
- 00860005748310 ()
- General tissue specimen container IVD, fixative/saline
- General-purpose absorbent tip applicator/swab, single-use
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM04-100
In Commercial Distribution
- 00860005748303 ()
- General tissue specimen container IVD, fixative/saline
- General-purpose absorbent tip applicator/swab, single-use
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
- 00860005745913 ()
- Ketone (acetoacetate) IVD, reagent
No Description
Adam Lawrence
TD-4279
In Commercial Distribution
- 00860005745906 ()
- Ketone (acetoacetate) IVD, reagent
The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures.
The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site.
The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
ENDO GI MEDICAL LTD
Delivery System
In Commercial Distribution
- 00860005738250 ()
- 10860005738257 ()
- Polymeric biliary stent, non-bioabsorbable
The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures.
The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site.
The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
ENDO GI MEDICAL LTD
Delivery System
In Commercial Distribution
- 00860005738243 ()
- Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible.
The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 140 mm stent preloaded on the Delivery System.
A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent (140mm)
In Commercial Distribution
- 00860005738236 ()
- Stent Length: 140 Millimeter
- Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible.
The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 80 mm stent preloaded on the Delivery System.
A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent (80mm)
In Commercial Distribution
- 00860005738229 ()
- Stent Length: 80 Millimeter
- Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible.
The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 110 mm stent preloaded on the Delivery System.
A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent
In Commercial Distribution
- 10860005738219 ()
- 00860005738212 ()
- Stent Length: 110 Millimeter
- Polymeric biliary stent, non-bioabsorbable
The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible.
The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site.
The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System.
A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Double-Stent
In Commercial Distribution
- 00860005738205 ()
- 10860005738202 ()
- Stent Length: 110 Millimeter
- Polymeric biliary stent, non-bioabsorbable
6Ft Light Gray Smoothbore CPAP Tubing - Slim Style
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA052TUB006SSLIM
In Commercial Distribution
- 00860005724840 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
10ft Gray Smoothbore CPAP Tubing
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA052TUB06
In Commercial Distribution
- 00860005724833 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
10ft Gray Smoothbore CPAP Tubing
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA052TUB10
In Commercial Distribution
- 00860005724826 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
Body composition scale. 200kg model.
LEXINGTON WELLNESS HOLDINGS INC.
S-5 (200kg)
In Commercial Distribution
- 10860005561732 ()
- 00860005561735 ()
- Bioelectrical body composition analyser
The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation).
This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.
Nightware Incorporated
100001
In Commercial Distribution
- 00860005400706 ()
- Sleep disorder interpretive software, patient-use
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-320-K
In Commercial Distribution
- 00860005396986 ()
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.
This is a subcomponent and is not transacted. See 810-P.
Spark Biomedical Inc.
810
In Commercial Distribution
- 00860005396979 ()
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
Spark Biomedical Inc.
210
In Commercial Distribution
- 00860005396962 ()
- 00860005396993 ()
- 00850052017064 ()
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.
This is a subcomponent and is not transacted. See 11-110-K.
Spark Biomedical Inc.
110
In Commercial Distribution
- 00860005396955 ()
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-310-K
In Commercial Distribution
- 00860005396948 ()
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for
optimal wound healing.
Mebo Life Science Inc.
40mm x 60mm
In Commercial Distribution
- 00860005367542 ()
- Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for
optimal wound healing
Mebo Life Science Inc.
60mm x 120mm
In Commercial Distribution
- 00860005367535 ()
- Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
35mmx160mm
In Commercial Distribution
- 00860005367528 ()
- 10860005367525 ()
- Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mmx100mm
In Commercial Distribution
- 00860005367511 ()
- 10860005367518 ()
- Wound-nonadherent dressing, absorbent, non-antimicrobial
FirstPlug Screw Channel Barrier 210cm
35newtons L.L.C.
P000017-005
In Commercial Distribution
- 00860005367252 ()
P000017-005
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-004
In Commercial Distribution
- 00860005367238 ()
P000017-004
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-003
In Commercial Distribution
- 00860005367221 ()
P000017-003
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-001
In Commercial Distribution
- 00860005367207 ()
P000017-001
- Antimicrobial dental prosthesis/implant plug