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Multi-Parameter Physiological Patient Monitor
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
LW8 Lite
In Commercial Distribution
- 00860003504017 ()
- General-purpose multi-parameter bedside monitor
- Neonatal multi-parameter bedside monitor
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons.
IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution
- 00860003478707 ()
000-0219
- Multi-parameter urinary monitoring system catheter set
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution
- 00860003469880 ()
LLO00002MB
- Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution
- 00860003469866 ()
LLO00002BR
- Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution
- 00860003469842 ()
LLO00002GR
- Air-conduction hearing aid, receiver-in-canal
hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution
- 00860003469828 ()
- Otoscope, direct
No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution
- 00860003469811 ()
- Tone audiometer
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution
- 10860003469801 ()
- 00860003469804 ()
Lumen 155
- Air-conduction hearing aid, behind-the-ear
ClearFit VDI Large
LONGEVITI NEURO SOLUTIONS LLC
171718
In Commercial Distribution
- 00860003416310 ()
- Cranial resinous compound
ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution
- 00860003416303 ()
- Cranial resinous compound
Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution
- 00860003372906 ()
- Natural conception assistance kit
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
None
In Commercial Distribution
- 00860003340608 ()
- Infusion pump medication-dosage application software
SPIWay Endonasal Access Guide Size Medium
SPIWAY LLC
SP005
In Commercial Distribution
- 00860003136416 ()
- 10860003136413 ()
SP005
- Intranasal splint, non-biodegradable
SPIWay Endonasal Access Guide Size Large
SPIWAY LLC
SP004
In Commercial Distribution
- 00860003136409 ()
- 10860003136406 ()
SP004
- Intranasal splint, non-biodegradable
One handed use
No lancing device required
Automatic needle retraction
Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
PureCSafety100
In Commercial Distribution
- 10860003125561 ()
- 00860003125564 ()
- Needle Gauge: 30 Gauge
- Manual blood lancing device, single-use
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics
and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution
- 00860003118399 ()
- Knee femur stem prosthesis
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution
- 00860003118368 ()
- Medical networking interface unit
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
Canary Medical USA LLC
43-5571-058-14
In Commercial Distribution
- 00860003118351 ()
- Knee tibia prosthesis trial, reusable
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution
- 00860003118320 ()
- Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution
- 00860003118313 ()
- Medical networking interface unit
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Canary Medical USA LLC
43-5570-058-14
In Commercial Distribution
- 00860003118306 ()
- Knee femur stem prosthesis
The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted on a fabric belt. The vibration pack is secured tightly against the lower back with a strap that is buckled in the front and pulled tight by the patient. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. After belt placement and before the beginning of each treatment session, the Osteoboost performs a fit check and a calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibration step typically takes 5-20 seconds. The device is available in three sizes and each size adjusts in belt length 5-10 inches. The size range accommodates a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, administer treatment during activities that involve standing and walking, such as getting ready in the morning, cooking, doing the dishes, other light household chores, going for a walk, and walking the dog.
Bone Health Technologies, Inc
Large
Not in Commercial Distribution
- 00860003039748 ()
FGN-09-3004
- Circulatory/musculoskeletal vibration therapy unit, hand-held
The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted on a fabric belt. The vibration pack is secured tightly against the lower back with a strap that is buckled in the front and pulled tight by the patient. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. After belt placement and before the beginning of each treatment session, the Osteoboost performs a fit check and a calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibration step typically takes 5-20 seconds. The device is available in three sizes and each size adjusts in belt length 5-10 inches. The size range accommodates a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, administer treatment during activities that involve standing and walking, such as getting ready in the morning, cooking, doing the dishes, other light household chores, going for a walk, and walking the dog.
Bone Health Technologies, Inc
Medium
Not in Commercial Distribution
- 00860003039731 ()
FGN-09-3003
- Circulatory/musculoskeletal vibration therapy unit, hand-held
The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted on a fabric belt. The vibration pack is secured tightly against the lower back with a strap that is buckled in the front and pulled tight by the patient. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. After belt placement and before the beginning of each treatment session, the Osteoboost performs a fit check and a calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibration step typically takes 5-20 seconds. The device is available in three sizes and each size adjusts in belt length 5-10 inches. The size range accommodates a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, administer treatment during activities that involve standing and walking, such as getting ready in the morning, cooking, doing the dishes, other light household chores, going for a walk, and walking the dog.
Bone Health Technologies, Inc
Small
Not in Commercial Distribution
- 00860003039724 ()
FGN-09-3002
- Circulatory/musculoskeletal vibration therapy unit, hand-held
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Miach Orthopaedics, Inc.
1000
In Commercial Distribution
- 00860002987804 ()
- Joint cartilage biomatrix implant
Flexible Access Port Kit
Cannuflow, Inc.
SportPort 6.5 x 6
In Commercial Distribution
- 20860002896940 ()
- 00860002896946 ()
- Lumen/Inner Diameter: 6.5 Millimeter
- Length: 6 Centimeter
Sport 6-6
- Arthroscopic access cannula, single-use
Flexible Access Portal Kit
Cannuflow, Inc.
SportPort 8.5 x 6
In Commercial Distribution
- 20860002896933 ()
- 00860002896939 ()
- Lumen/Inner Diameter: 8.5 Millimeter
- Length: 6 Centimeter
SPORT 8-6
- Arthroscopic access cannula, single-use
Filtered tubing set to attach MicroDryer to endoscope
GI Scientific LLC
Filtered Air Tubing Set
In Commercial Distribution
- 00860002853116 ()
- 00860002853178 ()
VMD-06-00008
- Surgical instrument/endoscope cleaning utensil, single-use
Flexible endoscope channel dryer
GI Scientific LLC
Endoscope Channel Dryer Large
In Commercial Distribution
- 00860002853116 ()
- 00860002853161 ()
VDL-06-00006
- Surgical instrument/endoscope cleaning utensil, single-use
PC Based Wireless 12 Lead EKG Device
MEMTEC CORPORATION
MobileECG System
In Commercial Distribution
- 00860002827315 ()
- Electrocardiograph, professional, single-channel