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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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None - 00886874110041

CAMERA HEAD STERILE ADAPTER
INTUITIVE SURGICAL, INC.
311613
In Commercial Distribution

  • 00886874110041 ()

  • Outer Diameter: 45 Millimeter


  • Patient surgical drape, reusable

None - 10886874111007

BLUE BLADE
INTUITIVE SURGICAL, INC.
400152
In Commercial Distribution

  • 10886874111007 ()
  • 00886874111000 ()

  • Angle: 15 degree


  • Manual scalpel blade, single-use

Senhance - 00815440021634

Bipolar Maryland Dissector
Asensus Surgical, Inc.
X0007309
In Commercial Distribution

  • 00815440021634 ()

  • Outer Diameter: 3 Millimeter
220-11010

  • Robotic electrosurgical instrument, bipolar, reusable

EndoWrist;daVinci Si - 00886874111451

ENDOPASS DELIVERY
INTUITIVE SURGICAL, INC.
420170
Not in Commercial Distribution

  • 00886874111451 ()

  • Outer Diameter: 8 Millimeter


  • Ligation clip cartridge holder

None - 00886874111086

HARMONIC ACE
INTUITIVE SURGICAL, INC.
400272
In Commercial Distribution

  • 00886874111086 ()
  • 10886874111083 ()

  • Outer Diameter: 5 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

None - 00886874111048

TIP COVER ACCESSORY
INTUITIVE SURGICAL, INC.
400180
In Commercial Distribution

  • 10886874111045 ()
  • 00886874111048 ()
  • 30886874111049 ()

  • Outer Diameter: 8 Millimeter


  • Electrosurgical system monitor/shield

None - 00886874110997

CANNULA SEAL
INTUITIVE SURGICAL, INC.
400077
In Commercial Distribution

  • 10886874110994 ()
  • 00886874110997 ()

  • Lumen/Inner Diameter: 8 Millimeter


  • Laparoscopic access cannula seal, single-use

EndoWrist;daVinci Si - 00886874111475

MARYLAND BIPOLAR FORCEPS
INTUITIVE SURGICAL, INC.
420172
In Commercial Distribution

  • 00886874111475 ()

  • Outer Diameter: 8 Millimeter


  • Robotic electrosurgical instrument, bipolar, reusable

Force Feedback - 00886874125588

Force Feedback Fenestrated Bipolar Forceps
INTUITIVE SURGICAL, INC.
476205
In Commercial Distribution

  • 00886874125588 ()

  • Outer Diameter: 8 Millimeter


  • Robotic electrosurgical instrument, bipolar, reusable

Remote Network Station - 00851725007283

No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490
In Commercial Distribution

  • 00851725007283 ()
RNS-6804-7490

  • Centralized patient monitor

Remote Network Station - 00851725007221

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480
In Commercial Distribution

  • 00851725007221 ()
RNS-6804-7480

  • Centralized patient monitor

Remote Network Station - 00851725007207

No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor

Remote Network Station - 00851725007177

No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor

ATLAS Workstation - 00850011306949

The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system

Epidural Disposable Kit - 00618874601102

Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6011
In Commercial Distribution

  • 00618874601102 ()


  • Electronic epidural space locator pressure-sensing set

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

BRAEBON MediByte - B14088900

Cable to connect MediByte to a computer for configuration and data upload.
Braebon Medical Corporation
8890
In Commercial Distribution

  • B14088900 ()
8890

  • Electrical-only medical device connection cable, reusable

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501034

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD

Mediworks - 06945087500002

Corneal topography system
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
DEA520
In Commercial Distribution

  • 06945087500002 ()


  • Corneal topography system

TOPOGRAPHIC MODELING SYSTEM - 04582273612129

with 31 cone
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612129 ()


  • Corneal topography system

Topographic Modeling System - 04582273603714

No Description
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution



  • Corneal topography system

TOPOGRAPHIC MODELING SYSTEM - 04582273612099

100V
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612099 ()


  • Corneal topography system

WAVELIGHT ALLEGRO TOPOLYZER - 00380659907678

WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system

Medmont Meridia Advanced Topographer Vantage - 09349221000132

No Description
MEDMONT INTERNATIONAL PTY LTD
Vantage
In Commercial Distribution

  • 09349221000132 ()


  • Corneal topography system

Medmont Meridia Advanced Topographer Classic - 09349221000118

No Description
MEDMONT INTERNATIONAL PTY LTD
Classic
In Commercial Distribution

  • 09349221000118 ()


  • Corneal topography system

Medmont Meridia Advanced Topographer Professional - 09349221000101

No Description
MEDMONT INTERNATIONAL PTY LTD
Professional
In Commercial Distribution

  • 09349221000101 ()


  • Corneal topography system

Medmont Corneal Topographer E300 USB - 09349221000033

No Description
MEDMONT INTERNATIONAL PTY LTD
E300 USB
Not in Commercial Distribution

  • 09349221000033 ()


  • Corneal topography system

IOL-Station - 04987669100844

The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.20
In Commercial Distribution

  • 04987669100844 ()


  • Corneal topography system

IOL-Station - 04987669200780

The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.21
In Commercial Distribution

  • 04987669200780 ()


  • Corneal topography system

ATLAS Corneal Topography System - 04057748081118

The ZEISS ATLAS Corneal Topography System is intended to measure and analyze the corneal curvature of the eye.
Carl Zeiss Meditec, Inc.
9000
Not in Commercial Distribution

  • 04057748081118 ()


  • Corneal topography system

ESSILOR - 08034028770517

BIOMETER - TOPOGRAPHER
VISIA IMAGING SRL
MYOPIA EXPERT 700
In Commercial Distribution

  • 08034028770517 ()
BMT00004

  • Corneal topography system

MYAH - 08034028770487

No Description
VISIA IMAGING SRL
MYAH
In Commercial Distribution

  • 08034028770487 ()
42-0000983US

  • Corneal topography system

MYOPIA EXPERT 700 - 08034028770463

BIOMETER - TOPOGRAPHER
VISIA IMAGING SRL
MYOPIA EXPERT 700
In Commercial Distribution

  • 08034028770463 ()
BMT00004

  • Corneal topography system

MYAH - 08034028770456

No Description
VISIA IMAGING SRL
MYAH
In Commercial Distribution

  • 08034028770456 ()
42-0000983US

  • Corneal topography system

Corneal Topographer HTG-1 - 08800019600770

Corneal Topographer HTG-1
Huvitz Co., Ltd.
HTG-1
In Commercial Distribution

  • 08800019600770 ()
HTG-1

  • Corneal topography system

CASSINI - 08719326059600

Cassini is a Corneal Topography System. An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface.
Cassini Technologies B.V.
2.0,3.0
In Commercial Distribution

  • 08719326059600 ()


  • Corneal topography system

Myopia Master - 04049584029959

The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
68130
In Commercial Distribution

  • 04049584029959 ()


  • Corneal topography system

Myopia Master - 04049584029942

The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
68120
In Commercial Distribution

  • 04049584029942 ()


  • Corneal topography system

Pentacam AXL Wave - 04049584025357

While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye.
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
70020
In Commercial Distribution

  • 04049584025357 ()


  • Corneal topography system

Pentacam AXL - 04049584012333

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

Keratograph 5M - 04049584000477

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

Pentacam HR - 04049584000026

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

Pentacam - 04049584000019

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

WAVELIGHT REFRACTIVE SUITE - 00380659906060

ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990606
Not in Commercial Distribution

  • 00380659906060 ()

  • Weight: 188 Pound


  • Corneal topography system

Zurich Pressure Guidewire System - 00850022994005

No Description
ZURICH MEDICAL INC.
Model 100
In Commercial Distribution

  • 00850022994005 ()
308

  • Cardiac/peripheral vascular guidewire, single-use
  • Intravascular haemodynamic monitoring system guidewire

BD Intelliport - 00382905167041

KIT TABLET
BECTON, DICKINSON AND COMPANY
516704
In Commercial Distribution

  • 00382905167041 ()
516704

  • Intravenous injection automated detection/documentation system computer
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