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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XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
PerkinElmer Technologies GmbH & Co. KG
XRpad2 4336 HWC-M
In Commercial Distribution

  • 00812589020054 ()

  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 384 Millimeter
  • Weight: 3.2 Kilogram
95510981

  • Flat panel x-ray detector integration unit
Rechargeable Lithium-Ion Battery Charger for use with PerkinElmer XRpad Battery Only
Perkinelmer, Inc.
XRpad LBC
In Commercial Distribution

  • 00812589020139 ()

  • Weight: 1.1 Kilogram
  • Width: 259 Millimeter
  • Height: 113 Millimeter
  • Depth: 82 Millimeter
95510921H

  • Flat panel x-ray detector integration unit
SINGLE USE TEST CARD F/DUV 400
Aesculap AG
PV032SU
Not in Commercial Distribution

  • 04046955206858 ()
PV032SU

  • Surgical microscope filter
MRI Monitor Remote Tablet
IRADIMED CORP.
3885T
In Commercial Distribution

  • 00856038001201 ()
3885T

  • Portable computer
Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit
COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169944268 ()


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

  • 00643169438170 ()


  • Portable computer
Planning Station
Covidien LP
AED00172-30
In Commercial Distribution

  • 10884521545588 ()


  • Portable computer
superDimension Planning Station
Covidien LP
ILS-0726-PS
In Commercial Distribution

  • 10884521785861 ()


  • Portable computer
Planning Station
Covidien LP
AED00170-01
In Commercial Distribution

  • 10884521582835 ()


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

  • 00813024013372 ()
20010-2810-000

  • 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
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 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
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
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