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The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which
are guided through the aperture in the treatment objective .
The optical system focuses the laser beam into the corneal tissue.
The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty
- In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting
- Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
Additionally under class III:
The VisuMax Femtosecond Laser is indicated for use in small incision
lenticule extraction (SMILE) for the reduction or elimination of
myopia with or without astigmatism
• for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters,
• for cylinder from -0.75 diopters through -3.00 diopters,
• when refraction spherical equivalent is no greater in magnitude than 10.00 diopters,
in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VisuMax
In Commercial Distribution
- 04049471095036 ()
- Weight (basic unit) 470 kg
- Weight (PSS): 250 kg
- Weight (platform): 150 kg
- L x W: 4.00 m x 3.70 m
- Femtosecond ophthalmic solid-state laser system
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
80008-004
- Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-003
In Commercial Distribution
- 00840241600030 ()
80008-003
- Wearable defibrillation system defibrillator
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (single unit package).
CARDIOCOMMAND, INC.
2A re-man'd, single pack
In Commercial Distribution
- 10856233005155 ()
8002A-9999
- External pacemaker, transoesophageal pacing
Accessory kit with components for installation of the ThinPrep® 5000 processor with autoloader.
Hologic, Inc.
TP-5000 Autoloader Accessory Kit
In Commercial Distribution
- 15420045513952 ()
ASY-08988
- Microscope slide maker IVD
Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs
Zoll Medical Corporation
9131-001
9131-001
- External defibrillation electrode, adult, single-use
Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs
Cardiac Science Corporation
9131-001
In Commercial Distribution
- 00812394020102 ()
- External defibrillation electrode, adult, single-use
Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; re-manufactured, (single unit package).
CARDIOCOMMAND, INC.
Re-manufactured, single pack
In Commercial Distribution
- 10856233005179 ()
0101-9999
- External pacemaker, transoesophageal pacing
OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Smart Mini Implantable Pulse Generator (IPG)
(1) Allen #2 torque wrench
(1) Port Plug
Impulse Dynamics (usa) Inc.
Smart Mini
In Commercial Distribution
- 00810003380098 ()
10-B501-3-XX
- Cardiac contractility modulation system pulse generator
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-001
In Commercial Distribution
- 00855728005925 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system