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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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MotionSense Digital Goniometer - 15060808320092

MotionSense Digital Goniometer
ENMOVI LTD
007-00066-US
In Commercial Distribution

  • 15060808320092 ()
007-00066-US

  • Electronic goniometer/kinesiology sensor

MotionSense Knee Alignment Block - 15060808320030

No Description
ENMOVI LTD
MotionSense 2.0
In Commercial Distribution

  • 15060808320030 ()
007-00038-US

  • Electronic goniometer/kinesiology sensor

MotionSense Adhesive Refill Kit - 15060808320023

No Description
ENMOVI LTD
MotionSense 2.0
In Commercial Distribution

  • 15060808320023 ()
007-00037-US

  • Electronic goniometer/kinesiology sensor

CORI - 00885556809600

CORI KNEE TENSIONER
Smith & Nephew, Inc.
ROB10100
In Commercial Distribution

  • 00885556809600 ()
ROB10100

  • Orthopaedic knee-balance analyser, electrically-powered

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410388992

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard

XVI - 05060191071208

XVI Cassette F0
ELEKTA LIMITED
1527278
In Commercial Distribution

  • 05060191071208 ()


  • Radiation therapy digital imager

XVI - 05060191071192

XVI Cassette M10
ELEKTA LIMITED
1526927
In Commercial Distribution

  • 05060191071192 ()


  • Radiation therapy digital imager

XVI - 05060191071185

XVI Cassette L20
ELEKTA LIMITED
1526926
In Commercial Distribution

  • 05060191071185 ()


  • Radiation therapy digital imager

XVI - 05060191071178

XVI Cassette M20
ELEKTA LIMITED
1526925
In Commercial Distribution

  • 05060191071178 ()


  • Radiation therapy digital imager

XVI - 05060191071161

XVI Cassette S20
ELEKTA LIMITED
1526924
In Commercial Distribution

  • 05060191071161 ()


  • Radiation therapy digital imager

XVI - 05060191071154

XVI Cassette L2
ELEKTA LIMITED
1526919
In Commercial Distribution

  • 05060191071154 ()


  • Radiation therapy digital imager

XVI - 05060191071147

XVI Cassette M2
ELEKTA LIMITED
1526918
In Commercial Distribution

  • 05060191071147 ()


  • Radiation therapy digital imager

XVI - 05060191071130

XVI Cassette L10
ELEKTA LIMITED
1526917
In Commercial Distribution

  • 05060191071130 ()


  • Radiation therapy digital imager

XVI - 05060191071123

XVI Cassette F1
ELEKTA LIMITED
1526914
In Commercial Distribution

  • 05060191071123 ()


  • Radiation therapy digital imager

XVI - 05060191071116

XVI Cassette M15
ELEKTA LIMITED
1526911
In Commercial Distribution

  • 05060191071116 ()


  • Radiation therapy digital imager

XVI - 05060191071109

XVI Cassette S10
ELEKTA LIMITED
1526910
In Commercial Distribution

  • 05060191071109 ()


  • Radiation therapy digital imager

XVI - 05060191071093

XVI Cassette 15x15
ELEKTA LIMITED
1526909
In Commercial Distribution

  • 05060191071093 ()


  • Radiation therapy digital imager

iViewGT™ - 05060191071055

iViewGT
ELEKTA LIMITED
1526752
In Commercial Distribution

  • 05060191071055 ()


  • Radiation therapy digital imager

XVI - 05060191071048

XVI
ELEKTA LIMITED
1526749
In Commercial Distribution

  • 05060191071048 ()


  • Radiation therapy digital imager

I2C (IBA Image Guided Therapy Console) - 05404013831906

Image Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013831906 ()
NA

  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013831333

Image-Guided Therapy console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013831333 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013831258

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013831258 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013830923

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013830923 ()
NA

  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013830916

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013830916 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013830909

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013830909 ()
NA

  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013830626

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013830626 ()
NA

  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013830534

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013830534 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013802012

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013802012 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013834013

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013834013 ()


  • Radiation therapy digital imager

I2C (IBA Image-Guided Therapy Console) - 05404013833313

Image-Guided Therapy Console
Ion Beam Applications SA
adaPTinsight
In Commercial Distribution

  • 05404013833313 ()
NA

  • Radiation therapy digital imager

NA - 00613994521781

COVER 5441 DISPOSABLE GLBL 3PK PACK
MEDTRONIC, INC.
5441
Not in Commercial Distribution

  • 00613994521781 ()


  • External pacemaker cover

NA - 00643169305120

COVER EPG 53922US 3 PK MKT US
MEDTRONIC, INC.
53922US
In Commercial Distribution

  • 00643169305120 ()


  • External pacemaker cover

Micro C Load Bearing Cassette Plate, ACSY-S009 - 00860008892751

No Description
OXOS Medical, Inc.
ACSY-S009
In Commercial Distribution

  • 00860008892751 ()


  • Flat panel x-ray detector/film cassette weight-bearing protector

BR Surgical, LLC - 00840183528614

Keyboard for Image Capture System
BR Surgical, LLC
BR900-1306
In Commercial Distribution

  • 00840183528614 ()
BR900-1306

  • Computer/medical device keyboard

TBI Detector 110V - 08717953004031

The TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forwarded to the Theraview imaging software.
Cablon Medical B.V.
C01-05-02
In Commercial Distribution

  • 08717953004031 ()
C01-05-02

  • Radiation therapy digital imager

KEYBOARD - 04953170222542

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1463
In Commercial Distribution

  • 04953170222542 ()


  • Computer/medical device keyboard

KEYBOARD - 04953170214493

MAJ-1428 KEYBOARD EVIS EXERA II
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1428
In Commercial Distribution

  • 04953170214493 ()


  • Computer/medical device keyboard

VISERA VIDEO SYSTEM CENTER - 04953170142055

MAJ-1124 VISERA SYSTEM KEYBOARD
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1124
In Commercial Distribution

  • 04953170142055 ()


  • Computer/medical device keyboard

KEY BOARD - 04953170026324

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-844
In Commercial Distribution

  • 04953170026324 ()


  • Computer/medical device keyboard
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