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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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Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01114
In Commercial Distribution

  • 03615020000724 ()


  • Phoropter, electric
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01014
In Commercial Distribution

  • 03615020000694 ()


  • Phoropter, electric
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01112
In Commercial Distribution

  • 03615020000663 ()


  • Phoropter, electric
3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
ESSILOR INTERNATIONAL
OCT2JT
In Commercial Distribution

  • 03615020000489 ()


  • Retinal optical coherence tomography system
Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
ESSILOR INTERNATIONAL
RET1IN
In Commercial Distribution

  • 03615020000465 ()


  • Ophthalmic fundus camera
Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
ESSILOR INTERNATIONAL
V01012
In Commercial Distribution

  • 03615020000427 ()


  • Phoropter, electric
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL450L
Not in Commercial Distribution

  • 03615020000342 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL450H
Not in Commercial Distribution

  • 03615020000335 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL400L
Not in Commercial Distribution

  • 03615020000328 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL400H
Not in Commercial Distribution

  • 03615020000311 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL350L
Not in Commercial Distribution

  • 03615020000304 ()


  • Ophthalmic examination slit lamp
Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
ESSILOR INTERNATIONAL
SL350H
Not in Commercial Distribution

  • 03615020000298 ()


  • Ophthalmic examination slit lamp
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis
ESSILOR INTERNATIONAL
ALM700
In Commercial Distribution

  • 03615020000120 ()


  • Automated lensmeter
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis
ESSILOR INTERNATIONAL
ALM500
In Commercial Distribution

  • 03615020000038 ()


  • Automated lensmeter
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
g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation.
g.tec medical engineering GmbH
1
In Commercial Distribution

  • EBCI11500 ()
1150

  • Cortical electrode
The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2070
In Commercial Distribution

  • EAMITRI20700 ()
TRI2070

  • Noninvasive vascular ultrasound system
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2010
Not in Commercial Distribution

  • EAMITRI20100 ()

  • Height: 7 Centimeter
  • Outer Diameter: 23 Centimeter
TRI2010

  • Noninvasive vascular ultrasound system
CARESCAPE B650 MBB313 (ATO MODEL)
GE Healthcare Finland Oy
MBB313
In Commercial Distribution

  • 00840682143806 ()


  • General-purpose multi-parameter bedside monitor
No Description
GE MEDICAL SYSTEMS
PRISTINA 0.0
In Commercial Distribution

  • 00840682143516 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
No Description
GE MEDICAL SYSTEMS
SIM1
In Commercial Distribution

  • 00840682143486 ()


  • Mammographic x-ray system stereotactic unit
No Description
GE Healthcare Austria GmbH & Co OG
RM7C
In Commercial Distribution

  • 00840682143271 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
B125 V1.5 PATIENT MONITOR ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
B125 Patient Monitor
Not in Commercial Distribution

  • 00840682138581 ()


  • General-purpose multi-parameter bedside monitor
B105 V1.5 PATIENT MONITOR ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
B105 Patient Monitor
Not in Commercial Distribution

  • 00840682138574 ()
2099000-003

  • General-purpose multi-parameter bedside monitor
No Description
PARALLEL DESIGN
L3-12-RS
In Commercial Distribution

  • 00840682136075 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
MAC 600
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
600
In Commercial Distribution

  • 00840682134859 ()
2048726-001

  • Electrocardiograph, professional, multichannel
MAC VU360
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
VU360
In Commercial Distribution

  • 00840682125499 ()
2030360-001

  • Electrocardiograph, professional, multichannel
No Description
GE Healthcare Austria GmbH & Co OG
C2-9-RS
In Commercial Distribution

  • 00840682125420 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
CAM CONNECT 14 WITH BARCODE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Connect 14 with Barcode
In Commercial Distribution

  • 00840682125291 ()
2091685-001

  • Electrocardiograph, professional, multichannel
No Description
PARALLEL DESIGN
L2-9VN-D
In Commercial Distribution

  • 00840682124768 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Needle holder for use during haemorrhoidal artery ligation.
AMI Agency for Medical Innovations GmbH
AHN 006
In Commercial Distribution

  • EAMIAHN0060 ()
AHN 006

  • Suturing needle holder, reusable
No Description
ECHOSENS
FibroScan 230
In Commercial Distribution

  • 03662264001222 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 430 MINI+
In Commercial Distribution



  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 530 Compact
In Commercial Distribution



  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 630
In Commercial Distribution

  • 03662264001161 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 430 MINI+
In Commercial Distribution

  • 03662264001147 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 530 Compact
In Commercial Distribution

  • 03662264001062 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 502 Touch
In Commercial Distribution

  • 03662264001048 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
FibroScan 502 Touch
In Commercial Distribution

  • 03662264001031 ()


  • Hepatic ultrasound elastography system
No Description
ECHOSENS
XL+
In Commercial Distribution

  • 03662264000072 ()


  • Hepatic ultrasound elastography system applicator
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