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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The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, UBM (high frequency B-scan),a nd pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual.
SONOMED, INC.
VuPad A/B/UBM/P
In Commercial Distribution

  • 00896100002064 ()
BUAP.580

  • Ophthalmic ultrasound imaging system
The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan, UBM (high frequency B-scan), and pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe, power supply, foot switch and user manual.
SONOMED, INC.
VuPad B/UBM/P
In Commercial Distribution

  • 00896100002057 ()
BUP.580

  • Ophthalmic ultrasound imaging system
The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable UBM tablet, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual.
SONOMED, INC.
VuPad UBM/P
In Commercial Distribution

  • 00896100002040 ()
UP.580

  • Ophthalmic ultrasound imaging system
The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes A-Scan, B-Scan and pachymeter capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable tablet, 12 MHz B-probe, 10 MHz A-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
SONOMED, INC.
VuPad A/B/P
In Commercial Distribution

  • 00896100002033 ()
BAP.580

  • Ophthalmic ultrasound imaging system
The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad BP is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan tablet, 12 MHz B-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
SONOMED, INC.
VuPad BP
In Commercial Distribution

  • 00896100002026 ()
BP.580

  • Ophthalmic ultrasound imaging system
The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator manual.
SONOMED, INC.
VuPad AP
In Commercial Distribution

  • 00896100002019 ()
AP.580

  • Ophthalmic ultrasound imaging system
Veterinary
ACCUTOME, INC.
24-6300-G-V
In Commercial Distribution

  • 00897826002277 ()


  • Ophthalmic ultrasound imaging system
Veterinary
ACCUTOME, INC.
24-6400-V
In Commercial Distribution

  • 00897826002239 ()
24-6400-V

  • Ophthalmic ultrasound imaging system
Veterinary
ACCUTOME, INC.
24-6100-V
In Commercial Distribution

  • 00897826002222 ()
24-6100-V

  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002215 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002208 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution

  • 00897826002192 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
7.00.02-U
In Commercial Distribution

  • 00897826002185 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002178 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002161 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution

  • 00897826002154 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-6400
In Commercial Distribution

  • 00897826002062 ()
24-6400

  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-6300
In Commercial Distribution

  • 00897826002048 ()
24-6300

  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-6100
In Commercial Distribution

  • 00897826002031 ()
24-6100

  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-4400
In Commercial Distribution

  • 00897826002024 ()
24-4400

  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000P
In Commercial Distribution

  • 06973211070756 ()


  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000A
In Commercial Distribution

  • 06973211070749 ()


  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000C
In Commercial Distribution

  • 06973211070718 ()


  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000B
In Commercial Distribution

  • 06973211070701 ()


  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000AP
In Commercial Distribution

  • 06973211070640 ()


  • Ophthalmic ultrasound imaging system
No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000A
In Commercial Distribution

  • 06973211070633 ()


  • Ophthalmic ultrasound imaging system
MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
Meda Co., Ltd
MD-320W
In Commercial Distribution

  • 06948941132005 ()


  • Ophthalmic ultrasound imaging system
MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.
Meda Co., Ltd
MD-1000A
In Commercial Distribution

  • 06948941111109 ()


  • Ophthalmic ultrasound imaging system
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
MD-2300S
In Commercial Distribution

  • 06948941102237 ()


  • Ophthalmic ultrasound imaging system
ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
ODM-2200
In Commercial Distribution

  • 06948941102220 ()


  • Ophthalmic ultrasound imaging system
ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
ODM-2100
In Commercial Distribution

  • 06948941102213 ()


  • Ophthalmic ultrasound imaging system
ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865012331 ()

  • 1 Each
6651170D

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution

  • 00847865002448 ()

  • 1 Each
6651170C

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic
BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution

  • 03610520506349 ()

  • 1 Each
6653775A

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
Zimmer, Inc.
110038053
In Commercial Distribution

  • 00889024579705 ()

  • 0 Degree, Size C-D
110038053

  • Device sterilization/disinfection container, reusable
No Description
Zimmer, Inc.
82-0156-859-19
In Commercial Distribution

  • 00889024472563 ()

  • Height: 14 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-19

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-18
In Commercial Distribution

  • 00889024472556 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 13 Millimeter
82-0156-859-18

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-17
In Commercial Distribution

  • 00889024472549 ()

  • Height: 12 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-17

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-16
In Commercial Distribution

  • 00889024472532 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 11 Millimeter
82-0156-859-16

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-15
In Commercial Distribution

  • 00889024472525 ()

  • Height: 10 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-15

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-14
In Commercial Distribution

  • 00889024472518 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 14 Millimeter
82-0156-859-14

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-13
In Commercial Distribution

  • 00889024472501 ()

  • Height: 13 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-13

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-12
In Commercial Distribution

  • 00889024472495 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 12 Millimeter
82-0156-859-12

  • Knee tibia prosthesis trial, reusable
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