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The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
of the brain and/or through the attachment of multiple electrodes at various locations to aid in
monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,
converts it into digital form and passes it on to a host computer running appropriate software. The
device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
80-Channel Amplifier
Not in Commercial Distribution
- EBCI70010 ()
- Channel Number 80
7001
- Multiple physiological signal amplifier
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid and accurate, manual IO access to all seven sites.
Product Description
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous (IO) vascular access. The T.A.L.O.N. allows providers rapid and accurate IO access to all seven sites. The T.A.L.O.N. delivers life-saving fluids and medications rapidly and accurately for casualty resuscitation.
T.A.L.O.N. is the first and only FDA-cleared manual IO device with 7-site access: sternum, bilateral proximal humerus, bilateral proximal tibia, and bilateral distal tibia. A single T.A.L.O.N. provides IO access—there are no powered tools or multiple needles necessary and no special removal tool is required. Simple step-by-step instructions and minimal insertion pressure is required to ensure that combat lifesavers and medics can use the T.A.L.O.N. effectively with proper training.
Capabilities
• 7-Site IO Vascular Access
• Simple Delivery of life-saving fluids and medication
• Rapid Resuscitation
Product Attributes
• Access to any IO site with one manual device
• No need for additional devices, multiple needles or special removal tools
• Meets CoTCCC recommendations for IO devices
Clinical Benefits
• First and only FDA-cleared manual IO device with 7-site access:
o Sternum
o Bilateral proximal humerus
o Bilateral proximal tibia
o Bilateral distal tibia
• Delivers fluids and medications rapidly and safely
Safeguard US Operating, LLC
00
Not in Commercial Distribution
- M68980081001 ()
80-081
- Intraosseous infusion kit
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid and accurate, manual IO access to all seven sites.
Product Description
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous (IO) vascular access. The T.A.L.O.N. allows providers rapid and accurate IO access to all seven sites. The T.A.L.O.N. delivers life-saving fluids and medications rapidly and accurately for casualty resuscitation.
T.A.L.O.N. is the first and only FDA-cleared manual IO device with 7-site access: sternum, bilateral proximal humerus, bilateral proximal tibia, and bilateral distal tibia. A single T.A.L.O.N. provides IO access—there are no powered tools or multiple needles necessary and no special removal tool is required. Simple step-by-step instructions and minimal insertion pressure is required to ensure that combat lifesavers and medics can use the T.A.L.O.N. effectively with proper training.
Capabilities
• 7-Site IO Vascular Access
• Simple Delivery of life-saving fluids and medication
• Rapid Resuscitation
Product Attributes
• Access to any IO site with one manual device
• No need for additional devices, multiple needles or special removal tools
• Meets CoTCCC recommendations for IO devices
Clinical Benefits
• First and only FDA-cleared manual IO device with 7-site access:
o Sternum
o Bilateral proximal humerus
o Bilateral proximal tibia
o Bilateral distal tibia
• Delivers fluids and medications rapidly and safely
Safeguard US Operating, LLC
80-081
Not in Commercial Distribution
- M6898008100 ()
80-081
- Intraosseous infusion kit
VIDEOSTAR II is a binocular freefield videonystagmoscope device. It transcribes the image of both eyes on the computer screen. It helps to asses the reaction of the patient viewing his eyes and its nystagmus during testing. The device consists of a goggle equipped with two cameras and an infrared mirror that enables to record both eye's movement without denying patient's field of view a removable cover to set the patient in total darkness and software running on a computer.
Instrumentation Difra SA
VIDEOSTAR II
In Commercial Distribution
- B516220920 ()
22092
- Posturography system platform
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
- EBCI11700 ()
1170
- Physical therapy transcutaneous neuromuscular electrical stimulation system
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable.
The Calibration body EM is provided non-sterile and is intended to be sterilized by the user.
The Calibration body EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution
- B057U1038020 ()
U1 038 02
- Electromagnetic surgical navigation device tracking system
Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders.
Alivecor, Inc.
AC-027
In Commercial Distribution
- B210AC0270 ()
- Electrocardiograph, professional, multichannel
The CT Sim+, 5-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution
- B1365000R0 ()
805655
- Laser patient positioning system
The CT Sim+, 5-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution
- B1365000G0 ()
805658
- Laser patient positioning system
The CT Sim+, 5-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
SUN NUCLEAR CORP.
CT Sim+
In Commercial Distribution
- B1365000B0 ()
805659
- Laser patient positioning system