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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Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
In Commercial Distribution

  • B155EM40 ()
  • 04032767832866 ()


  • Portable computer
ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer
iLogic inReach;Planning Laptop
Covidien LP
AED00147-20
In Commercial Distribution

  • 10884521200364 ()


  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer
LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.
ORTHOSENSOR INC
Linkstation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818022635 ()
05000-500-B

  • Arthroplasty force sensor display unit
LinkStation MINI with United States and Canada power cord. Bluetooth only
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818022536 ()
05000-001-B

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with Continental Europe/ Korea power cord and additional label for Korea
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020563 ()
05000-507

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with Switzerland power cord
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020556 ()
05000-506

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with Italy power cord
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020549 ()
05000-505

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with United Kingdom and Ireland power cord
ORTHOSENSOR INC
Linkstation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020532 ()
05000-504

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with Continental Europe power cord
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020525 ()
05000-503

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020518 ()
05000-502

  • Arthroplasty force sensor display unit
LinkStation MINI Evaluation Kit with power cord for United States and Canada
ORTHOSENSOR INC
Linkstation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020501 ()
05000-500

  • Arthroplasty force sensor display unit
LinkStation MINI with Switzerland power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020495 ()
05000-006

  • Arthroplasty force sensor display unit
LinkStation MINI with Italy power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020488 ()
05000-005

  • Arthroplasty force sensor display unit
LinkStation MINI with United Kingdom and Ireland power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020471 ()
05000-004

  • Arthroplasty force sensor display unit
LinkStation MINI with Continental Europe/ Korea power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020464 ()
05000-003

  • Arthroplasty force sensor display unit
LinkStation MINI with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020457 ()
05000-002

  • Arthroplasty force sensor display unit
LinkStation MINI with United States and Canada power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020440 ()
05000-001

  • Arthroplasty force sensor display unit
LinkStation MINI with Continental Europe/ Korea power cord and additional label for Korea
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020006 ()
05000-007

  • Arthroplasty force sensor display unit
SYNERGY VISION TABLET
ARTHREX, INC.
AR-3200-1016
In Commercial Distribution

  • 00888867435797 ()
AR-3200-1016

  • Portable computer
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
No Description
Advanced Bionics AG
CI-6126
Not in Commercial Distribution

  • 07630016882944 ()


  • Portable computer
No Description
Advanced Bionics AG
CI-6126
Not in Commercial Distribution

  • 07630016882623 ()


  • Portable computer
No Description
Advanced Bionics AG
CI-6126
Not in Commercial Distribution

  • 07630016864650 ()


  • Portable computer
No Description
Advanced Bionics AG
CI-6126
Not in Commercial Distribution

  • 07630016862809 ()


  • Portable computer
No Description
Thoratec Corporation
105620
In Commercial Distribution

  • 00813024011804 ()
105620

  • Portable computer
No Description
Thoratec Corporation
105410
In Commercial Distribution

  • 00813024011781 ()
105410

  • Portable computer
No Description
Thoratec Corporation
105400
In Commercial Distribution

  • 00813024011767 ()
105400

  • Portable computer
No Description
Thoratec Corporation
20010-2810-000
In Commercial Distribution

  • 00813024013372 ()
20010-2810-000

  • Portable computer
Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
em4
In Commercial Distribution

  • B155EM40 ()


  • Portable computer
BiOM T2 Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
2001219
In Commercial Distribution

  • B15520012190 ()


  • Portable computer
ERC 2P Laptop Assembly US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_US
In Commercial Distribution

  • 00887517969132 ()
ERC2P-LAPTOP_P_US

  • Portable computer
ERC 2P Laptop Assembly UK
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_UK
In Commercial Distribution

  • 00887517969125 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_UK

  • Portable computer
ERC 2P Laptop Assembly EU
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_EU
In Commercial Distribution

  • 00887517969118 ()

  • Tools/Instruments
ERC2P-LAPTOP_P_EU

  • Portable computer
ERC 2P Laptop Assembly AR
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_AR
In Commercial Distribution

  • 00887517969101 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_AR

  • Portable computer
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000570262 ()


  • Portable computer
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027S
In Commercial Distribution

  • 00885556780879 ()
ROB10027S

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027
In Commercial Distribution

  • 00885556757451 ()
ROB10027

  • Portable computer
COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000102388 ()


  • Portable computer
OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block
Active Life Scientific, Inc.
OPD-907
In Commercial Distribution

  • 10860001719397 ()
  • 00860001719390 ()
OPD-907

  • Bone microindentation resistance measurement system
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution

  • 00860010168417 ()


  • Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution

  • 00860010168400 ()


  • Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit
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