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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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SONY - 04548736033917

IP Converter (SDI Optical)
SONY CORPORATION
NU-IP40S
In Commercial Distribution

  • 04548736033917 ()


  • Operating room audiovisual data/device management system

Vacuum Lock - 00628341930161

Vacuum Lock Cushion
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930168 ()
  • 00628341930161 ()
VB

  • Vacuum-mould patient positioning system

MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 - 04953170391767

MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-4
In Commercial Distribution

  • 04953170391767 ()


  • Operating room audiovisual data/device management system

CANON INC. - 04960999999708

No Description
CANON INC.
CXDI-801C Wireless
In Commercial Distribution

  • 04960999999708 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999999050

No Description
CANON INC.
CXDI-801G Wireless
In Commercial Distribution

  • 04960999999050 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999999043

No Description
CANON INC.
CXDI-401C Wireless
In Commercial Distribution

  • 04960999999043 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999989600

No Description
CANON INC.
CXDI-701C Wireless
In Commercial Distribution

  • 04960999989600 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999989587

No Description
CANON INC.
CXDI-701G Wireless
In Commercial Distribution

  • 04960999989587 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999988184

No Description
CANON INC.
CXDI-55C
In Commercial Distribution

  • 04960999988184 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999986647

No Description
CANON INC.
CXDI-55G
In Commercial Distribution

  • 04960999986647 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999974965

No Description
CANON INC.
CXDI-70C Wireless
In Commercial Distribution

  • 04960999974965 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999814735

No Description
CANON INC.
CXDI-501C
In Commercial Distribution

  • 04960999814735 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999814728

No Description
CANON INC.
CXDI-501G
In Commercial Distribution

  • 04960999814728 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999812601

No Description
CANON INC.
CXDI-401G COMPACT
In Commercial Distribution

  • 04960999812601 ()


  • Computed radiography digital imaging scanner

CANON INC. - 04960999810911

No Description
CANON INC.
CXDI-50RF
In Commercial Distribution

  • 04960999810911 ()


  • Computed radiography digital imaging scanner

MEDICAL CONTROL UNIT FOR ENDOSURGERY - 04953170286018

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286018 ()


  • Operating room audiovisual data/device management system

MEDICAL CONTROL UNIT FOR ENDOSURGERY - 04953170286001

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286001 ()


  • Operating room audiovisual data/device management system

Tissue-Tek® SmartWrite® - 00615233012494

Cassette Printer
SAKURA FINETEK U.S.A., INC.
9022
In Commercial Distribution

  • 00615233012494 ()
9022

  • Computed radiography digital imaging scanner

HELION - 00615521031688

Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System -Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031688 ()
VR401111-1DT

  • Operating room audiovisual data/device management system

HELION - 00615521031664

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031664 ()
VR401111-1T

  • Operating room audiovisual data/device management system

HELION - 00615521031657

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031657 ()
VR401111-1TND

  • Operating room audiovisual data/device management system

HELION - 00615521031640

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031640 ()
VR401111-2

  • Operating room audiovisual data/device management system

HELION - 00615521031633

Helion Video Integration System - Main Unit (in-room intallation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031633 ()
VR401111-2D

  • Operating room audiovisual data/device management system

HELION - 00615521031626

Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031626 ()
VR401111-2DT

  • Operating room audiovisual data/device management system

HELION - 00615521031619

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031619 ()
VR401111-2T

  • Operating room audiovisual data/device management system

HELION - 00615521031602

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB SSD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031602 ()
VR401111-3

  • Operating room audiovisual data/device management system

HELION - 00615521031596

Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 5 x 5 Input/Output HDMI video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031596 ()
VR401112

  • Operating room audiovisual data/device management system

HELION - 00615521031589

Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 4 x 4 Input/Output 4xHDMI 4xDisplay Port video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031589 ()
VR401113

  • Operating room audiovisual data/device management system

HELION - 00615521031572

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031572 ()
VR401111-1

  • Operating room audiovisual data/device management system

HELION - 00615521031886

Helion Unit for manage bidirectional A/V videoconferencing. Main Features: - Dual channel transmission support; - Control directly via Helion GUI and Touchscreen; - Connections with remote users or any third-party videoconferencing unit supporting H.323 and SIP communication protocols; - Video Input/Output: FullHD bidirectional full duplex (2 separate video channels); - Audio: bidirectional full-duplex; - Protocols:H.323 and SIP.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031886 ()
CM401326

  • Operating room audiovisual data/device management system
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