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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ECG Cable, 3 Attached Lead, Snap, AAMI, 1O'
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094033601 ()
008-0880-00

  • Multiple vital physiological parameter monitoring system, clinical
ENG CONTROL & TELEM 220V 50HZ W 8 SLOTS
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351248 ()
SCNODE-BAB-AKXFX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 8 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351231 ()
SCSYS-IAB-CDFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG int
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351224 ()
SCSYS-IAB-GDFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmi
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094350920 ()
SCSYS-HAB-GHFCA

  • Centralized patient monitor
SCS S4 FR 110V 60Hz 16S 8C Combination
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094349566 ()
SCSYS-ICE-FHFCX

  • Centralized patient monitor
FRE CTRL TELEM 110 S 16 T 8 S4 24
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348941 ()
SCNODE-BCA-BKXEX

  • Centralized patient monitor
FRENCH. 110V REDUNDANT
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348934 ()
SCNODE-GCA-XXDXX

  • Centralized patient monitor
Surveyor Central Station with X12+ via 608 MHz frequency and multiparameter bedside monitoring capabilities; French language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24 in. monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348927 ()
SCSYS-GCE-FHFCX

  • Centralized patient monitor
TELEM 220 VAC 32S 16C S4
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348095 ()
SCNODE-BAB-CLXFX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 16 hard wired patient monitoring slots and 16 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094348088 ()
SCSYS-IAB-PDFCA

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 24 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347197 ()
SCAC-AAA-DXCXX

  • Centralized patient monitor
ENG. 110V custom sl- CONTROL W DISPLAY
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347180 ()
SCNODE-DAA-EXXEX

  • Centralized patient monitor
No Description
Topcon Healthcare Solutions EMEA Oy
3.9.1
In Commercial Distribution

  • 06430078740265 ()


  • Medical image management system
Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience.
Topcon Healthcare Solutions EMEA Oy
3.8.1
In Commercial Distribution

  • 06430078740005 ()


  • Medical image management system
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000S
In Commercial Distribution

  • 06938396410063 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000
In Commercial Distribution

  • 06938396410049 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300T
In Commercial Distribution

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital
No Description
ICU MEDICAL, INC.
3375
In Commercial Distribution

  • 15019517053708 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-02
In Commercial Distribution

  • 14719878713099 ()


  • Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-PDL-01
In Commercial Distribution

  • 14719878713112 ()


  • Surgical planning/navigation-enhancement system
No Description
EMPATICA SRL
Care Portal
In Commercial Distribution

  • 00853858006263 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution

  • 00853858006232 ()
EMBP-CC-MS

  • Multiple vital physiological parameter monitoring system, home-use
Vitegra® pro with footswitch
Joimax GmbH
ICS1710FS
In Commercial Distribution

  • 04250337119852 ()

  • visual integration image capture system
ICS1710FS

  • Medical image management system
Vitegra® pro
Joimax GmbH
ICS1710
In Commercial Distribution

  • 04250337119845 ()

  • visual integration image capture system
ICS1710

  • Medical image management system
Adapter plate
Joimax GmbH
JESTTH
In Commercial Distribution

  • 04250337119821 ()
JESTTH

  • Medical image management system
joimax® Vitegra® DICOM module
Joimax GmbH
ICS0401D
In Commercial Distribution

  • 04250337119685 ()

  • License key for enabling the DICOM functionality
ICS0401D

  • Medical image management system
joimax® Vitegra® tablet mount set
Joimax GmbH
JESTTHS
In Commercial Distribution

  • 04250337117698 ()

  • VESA 75/100, charging station
JESTTHS

  • Medical image management system
joimax® Vitegra® Wireless Microphone Set
Joimax GmbH
ICWSR400S
In Commercial Distribution

  • 04250337117346 ()
ICWSR400S

  • Medical image management system
joimax® Vitegra® Tablet
Joimax GmbH
ICS0401T
In Commercial Distribution

  • 04250337116165 ()
ICS0401T

  • Medical image management system
Footswitch for Vitegra®3 for Video/Image capture
Joimax GmbH
ICFSV002
In Commercial Distribution

  • 04250337106371 ()
ICFSV002

  • Medical image management system
Vitegra®3 IO-Modul Image/Video Capture
Joimax GmbH
ICS1900IO
In Commercial Distribution

  • 04250337106364 ()
ICS1900IO

  • Medical image management system
joimax® Vitegra® Wireless Microphone Set
Joimax GmbH
ICWSR400
In Commercial Distribution

  • 04250337105312 ()
ICWSR400

  • Medical image management system
joimax® Rotate and Slope Adaptor for Vitegra®
Joimax GmbH
ICRA410G
In Commercial Distribution

  • 04250337105299 ()
ICRA410G

  • Medical image management system
joimax® Holding Arm, grey
Joimax GmbH
ICHA620G
In Commercial Distribution

  • 04250337102878 ()

  • 5 axes
ICHA620G

  • Medical image management system
joimax® Microphone
Joimax GmbH
ICWM0055
In Commercial Distribution

  • 04250337119944 ()
ICWM0055

  • Medical image management system
Vitegra® Pro Upgrade
Joimax GmbH
ICS1710.100
In Commercial Distribution

  • 04250337119937 ()
ICS1710.100

  • Medical image management system
joimax® Vitegra® Visual Integration System
Joimax GmbH
ICS0401S
In Commercial Distribution

  • 04250337115298 ()

  • Fully integrated Full HD documentation system
ICS0401S

  • Medical image management system
joimax® Vitegra® Control Unit
Joimax GmbH
ICS0401
In Commercial Distribution

  • 04250337115281 ()
ICS0401

  • Medical image management system
Vitegra®3 Visual Integration System
Joimax GmbH
ICS1900
In Commercial Distribution

  • 04250337103950 ()
ICS1900

  • Medical image management system
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