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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P16535-03
In Commercial Distribution

  • 00841517101596 ()
P16535

  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P22557-10
In Commercial Distribution

  • 00841517101589 ()
P22557

  • Extracorporeal ultrasound imaging transducer, hand-held
CODMAN HAKIM Valve Programmer, 100-240V
Cerenovus, Inc.
82-3190
Not in Commercial Distribution

  • 10886704041597 ()
823190

  • Cerebrospinal fluid shunt valve programmer
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution

  • 04049471095074 ()

  • Weight: 295 Kilogram
  • x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m


  • Ophthalmic excimer laser system
The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
72300
In Commercial Distribution

  • 04049584014085 ()

  • Weight: 14 Kilogram
  • Height: 520 Millimeter
  • Depth: 520 Millimeter
  • Width: 270 Millimeter


  • Ophthalmic tonometer, battery-operated
While rotating around the eye, the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70100
In Commercial Distribution

  • 04049584012333 ()

  • Weight: 7.9 Kilogram
  • Height: 430 Millimeter
  • Depth: 208 Millimeter
  • Width: 270 Millimeter


  • Corneal topography system
The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is reflected off the cornea. These data are analyzed by the computer.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
7700
In Commercial Distribution

  • 04049584000477 ()

  • Weight: 6.1 Kilogram
  • Height: 512 Millimeter
  • Depth: 400 Millimeter
  • Width: 275 Millimeter


  • Corneal topography system
The PARK 1 combines three measuring functions in one unit. Auto-Refractometer An infrared light source projects measuring light onto the retina of the eye from where it is reflected back to the shutter location. Sensitive sensor chips, or CCD cameras now register the deviation of the reflected light from the shutter location. The deviation depends on the ametropia. From that, an integrated microcomputer calculates the ametropia in D, based on the sphere, cylinder and cylinder axis position. 1 Measuring ocular / Patient eyepiece 4 Chin rest 2 Keratometer ring 5 Marking for the eye height 3 Pachycam camera glass cover Keratometer To determine the curvature of the cornea, a reflected image of the cornea is captured by a camera sensor and is measured. The reflection of test marks and of a ring is used as the reflected image. This allows the central radii of the cornea to be determined. Pachymeter The pachymetry principle uses Scheimpflug images of the cornea, which are analysed by a built-in computer. 600 Absolute data points are evaluated with the Scheimpflug image. The measuring range lies on a 4 mm slit through the apex. The slit light illuminates a sectional plane from the front surface of the cornea to the back surface. The transparent cells of the cornea scatter the slit light such that the sectional plane appears as if it were self-luminous. This is captured at an angle of 45° through the pupil by a camera, whereby the image plane of the camera is also tilted 45° to the optical axis of the camera lens, in order to sharply focus the light-scattering cornea plane onto the image plane of the camera (Scheimpflug image). Thanks to this arrangement, sharp sectional images of the cornea can be attained.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
65000
In Commercial Distribution

  • 04049584000217 ()

  • Weight: 12 Kilogram
  • Depth: 530 Millimeter
  • Width: 538 Millimeter
  • Height: 265 Millimeter


  • Ophthalmic refractometer, manual
The OCULUS Easyfield® has been designed for combined use as a screening unit with all associated options for immediate follow-up examination of suspicious findings. The most common examination grids and strategies for the central visual field up to 30° can be accessed. The Easyfield® offers pre programmed combinations for often needed examination routines. For example: Screening 24-2, SPARK Quick, Macula. You can also combine your own routines and then save them as a program.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
15005
In Commercial Distribution

  • 04049584000064 ()

  • Weight: 4.6 Kilogram
  • Height: 435 Millimeter
  • Depth: 450 Millimeter
  • Width: 275 Millimeter


  • Perimeter, automatic
The OCULUS Easyfield® has been designed for combined use as a screening unit with all associated options for immediate follow-up examination of suspicious findings. The most common examination grids and strategies for the central visual field up to 30° can be accessed. The Easyfield® offers pre programmed combinations for often needed examination routines. For example: Screening 24-2, SPARK Quick, Macula. You can also combine your own routines and then save them as a program.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
15000
In Commercial Distribution

  • 04049584000057 ()

  • Weight: 6.8 Kilogram
  • Height: 435 Millimeter
  • Depth: 540 Millimeter
  • Width: 316 Millimeter


  • Perimeter, automatic
The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70900
In Commercial Distribution

  • 04049584000026 ()

  • Height: 535 Millimeter
  • Depth: 360 Millimeter
  • Width: 280 Millimeter
  • Weight: 11 Kilogram


  • Corneal topography system
The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-model1 of the eye.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70700
In Commercial Distribution

  • 04049584000019 ()

  • Weight: 10.5 Kilogram
  • Height: 535 Millimeter
  • Depth: 360 Millimeter
  • Width: 280 Millimeter


  • Corneal topography system
No Description
H ROBOTICS INC.
RHSW
In Commercial Distribution

  • 08800101600015 ()


  • Ankle continuous passive motion exerciser
  • Hand/wrist continuous passive motion exerciser
  • Continuous passive motion joint exerciser
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-xxl
In Commercial Distribution

  • 14260671372599 ()
  • 04260671372592 ()

  • Length: 688 Millimeter
  • Width: 170 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-xl
In Commercial Distribution

  • 14260671372582 ()
  • 04260671372585 ()

  • Length: 610 Millimeter
  • Width: 170 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-l
In Commercial Distribution

  • 14260671372575 ()
  • 04260671372578 ()

  • Length: 610 Millimeter
  • Width: 170 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-m
In Commercial Distribution

  • 14260671372568 ()
  • 04260671372561 ()

  • Length: 520 Millimeter
  • Width: 140 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-s
In Commercial Distribution

  • 04260671372554 ()
  • 14260671372551 ()

  • Length: 410 Millimeter
  • Width: 115 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
A2534-xs
In Commercial Distribution

  • 04260671372547 ()
  • 14260671372544 ()

  • Length: 314 Millimeter
  • Width: 87 Millimeter


  • Blood pressure cuff, reusable
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
2001589-235
In Commercial Distribution

  • 04260671372233 ()

  • Length: 640 Millimeter
  • Width: 175 Millimeter


  • Blood pressure cuff, single-use
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