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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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RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX3900
In Commercial Distribution

  • 05055273205893 ()
RX3900

  • Multiple clinical chemistry analyser IVD, laboratory
LCD touch screen recording system with HDMI loop through. Software version update 1.7.14
Nds Surgical Imaging LLC
Evo4K130
Not in Commercial Distribution

  • 00817613020857 ()


  • Endoscopic video image processing unit
Grid 3D Image Distortion Analysis System- Includes One Phantom and 2 software licenses..
Modus Medical Devices Inc
100-1017
In Commercial Distribution

  • G34310010170 ()


  • Multi-modality therapeutic radiation phantom, test object
Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.
Reapplix ApS
2
In Commercial Distribution

  • 05714188308005 ()


  • Haematological concentrate system centrifuge
No Description
MONOBIND, INC.
IN016-E
In Commercial Distribution

  • 00816870024028 ()
IN016-E

  • Microplate reader IVD, automated/semi-automated
No Description
MONOBIND, INC.
IN015-E
In Commercial Distribution

  • 00816870024004 ()
IN015-E

  • Microplate reader IVD, automated/semi-automated
Scanner
Align Technology, Inc.
107806
In Commercial Distribution

  • 00816063020677 ()


  • Dental milling system, CAD/CAM, chairside
EIA microtiter plate analyzer
ARLINGTON SCIENTIFIC, INC.
NC-2700-000
In Commercial Distribution

  • 00816057020058 ()

  • Area/Surface Area: 1.99 Square meter
NC-2700-000

  • Microplate reader IVD, automated/semi-automated
No Description
MONOBIND, INC.
IN006
In Commercial Distribution

  • 00816870020075 ()
IN006

  • Microplate reader IVD, automated/semi-automated
MotionSense Application Version 1.5
ENMOVI LTD
SW-1.5-MSAPP
In Commercial Distribution

  • 55060808320168 ()
SW-1.5-MSAPP

  • Electronic goniometer/kinesiology sensor
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