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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Calibrator
Claronav Inc
950-ND-CAL
In Commercial Distribution

  • 07540209955938 ()
950-ND-CAL

  • Surgical planning/navigation-enhancement system
NaviTray
Claronav Inc
955-ND-NTRY
In Commercial Distribution

  • 07540209955921 ()
955-ND-NTRY

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT43)
Claronav Inc
955-ND-JTTB-001
In Commercial Distribution

  • 07540209955914 ()
955-ND-JTTB-001

  • Surgical planning/navigation-enhancement system
JawTracker T (JTT42)
Claronav Inc
955-ND-JTTC-001
In Commercial Distribution

  • 07540209955907 ()
955-ND-JTTC-001

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT41)
Claronav Inc
955-ND-JTTA-001
In Commercial Distribution

  • 07540209955891 ()
955-ND-JTTA-001

  • Surgical planning/navigation-enhancement system
Jaw Tracker 4U
Claronav Inc
955-ND-JTUC
In Commercial Distribution

  • 07540209955884 ()
955-ND-JTUC

  • Surgical planning/navigation-enhancement system
Jaw Tracker 4C
Claronav Inc
955-ND-JCOM
In Commercial Distribution

  • 07540209955877 ()
955-ND-JCOM

  • Surgical planning/navigation-enhancement system
Jaw Tracker 4B
Claronav Inc
955-ND-JBAT
In Commercial Distribution

  • 07540209955860 ()


  • Surgical planning/navigation-enhancement system
High Speed Handpiece Tracker (HPT HS)
Claronav Inc
955-ND-HPTG-002
Not in Commercial Distribution

  • 07540209955853 ()
955-ND-HPTG-002

  • Surgical planning/navigation-enhancement system
Low Speed Handpiece Tracker (HPT LS)
Claronav Inc
955-ND-HPTG-001
Not in Commercial Distribution

  • 07540209955846 ()
955-ND-HPTG-001

  • Surgical planning/navigation-enhancement system
Tracer 4
Claronav Inc
955-ND-TRTO (Version 4)
In Commercial Distribution

  • 07540209955839 ()
955-ND-TRTO

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT33)
Claronav Inc
955-ND-JTTB-000
In Commercial Distribution

  • 07540209955822 ()
955-ND-JTTB-000

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT32)
Claronav Inc
955-ND-JTTC-000
In Commercial Distribution

  • 07540209955815 ()
955-ND-JTTC-000

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT31)
Claronav Inc
955-ND-JTTA-000
In Commercial Distribution

  • 07540209955808 ()
955-ND-JTTA-000

  • Surgical planning/navigation-enhancement system
Jaw Tracker U
Claronav Inc
955-ND-JTVU
In Commercial Distribution

  • 07540209955792 ()
955-ND-JTVU

  • Surgical planning/navigation-enhancement system
Jaw Tracker C
Claronav Inc
955-ND-JTVC
In Commercial Distribution

  • 07540209955785 ()
955-ND-JTVC

  • Surgical planning/navigation-enhancement system
Jaw Tracker B
Claronav Inc
955-ND-JTVB
In Commercial Distribution

  • 07540209955778 ()
955-ND-JTVB

  • Surgical planning/navigation-enhancement system
Tracer 3
Claronav Inc
955-ND-TRTO (Version 3)
In Commercial Distribution

  • 07540209955761 ()
955-ND-TRTO

  • Surgical planning/navigation-enhancement system
Navident Training Kit for use with the Navident system
Claronav Inc
955-ND-NVTK
In Commercial Distribution

  • 07540209955044 ()


  • Surgical planning/navigation-enhancement system
Navident accessory kit for use with Navident System
Claronav Inc
955-ND-ACCK
In Commercial Distribution

  • 07540209955037 ()


  • Surgical planning/navigation-enhancement system
Navident Surgical Navigation System - Packaged System (including kits/accessories)
Claronav Inc
955-ND-ND, plus kits
In Commercial Distribution

  • 07540209955006 ()


  • Surgical planning/navigation-enhancement system
ZENITH 9000 SLIDE WIDE W/LOK
GF HEALTH PRODUCTS, INC.
ZZA99674-897
In Commercial Distribution

  • M368ZZA996748971 ()


  • Centralized patient monitor
BED Z9100 APS W/ LOK SLIDE WIDE
GF HEALTH PRODUCTS, INC.
ZZA99674
In Commercial Distribution

  • M368ZZA996741 ()


  • Centralized patient monitor
BED ZENITH APS SLIDE WIDE 240V
GF HEALTH PRODUCTS, INC.
ZZA9967406
In Commercial Distribution

  • M368ZZA99674061 ()


  • Centralized patient monitor
No Description
ICU MEDICAL, INC.
WW8214
In Commercial Distribution

  • 30610586038444 ()
  • 10610586038440 ()


  • Multiple vital physiological parameter monitoring system, clinical
EXAM TABLE W/OUTLET & DRAWER
GF HEALTH PRODUCTS, INC.
4200-DW-WG
In Commercial Distribution

  • M3684200DWWG1 ()


  • Centralized patient monitor
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713065 ()


  • Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713058 ()


  • Surgical planning/navigation-enhancement system
No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713041 ()


  • Surgical planning/navigation-enhancement system
The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS10
In Commercial Distribution

  • 07290013030047 ()
  • 27290013030041 ()
CMS10

  • Multiple vital physiological parameter monitoring system, clinical
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