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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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Acteon - 08052870660015

No Description
DENTAL XRAY COMPANY SRL
X-MIND prime
Not in Commercial Distribution

  • 08052870660015 ()


  • Stationary panoramic dental x-ray system, digital

NewTom - 08033837931416

Digital panoramic and cephalometric extra­oral X-­ray system.
CEFLA SOCIETA' COOPERATIVA
NewTom Giano (2D)
In Commercial Distribution

  • 08033837931416 ()
XGIAN2D

  • Stationary panoramic dental x-ray system, digital

myray - 08033837931409

Digital panoramic and cephalometric extra­oral X-­ray system.
CEFLA SOCIETA' COOPERATIVA
hyperion X9 (2D)
In Commercial Distribution

  • 08033837931409 ()
X92D015

  • Stationary panoramic dental x-ray system, digital

NewTom - 08033837931317

Extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
CEFLA SOCIETA' COOPERATIVA
NewTom GO (2D)
In Commercial Distribution

  • 08033837931317 ()
XNEWTGO

  • Stationary panoramic dental x-ray system, digital

myray - 08033837930914

Extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
CEFLA SOCIETA' COOPERATIVA
hyperion X5 (2D)
In Commercial Distribution

  • 08033837930914 ()
XHYPEX5

  • Stationary panoramic dental x-ray system, digital

Simplant - 07392532209413

Case Viewer
Dentsply Implants NV
Version 3.1
In Commercial Distribution

  • 07392532209413 ()
54500395IV31

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532208423

Simplant Editor
Dentsply Implants NV
Version 3.1
In Commercial Distribution

  • 07392532208423 ()
54500394E31

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532208416

Simplant View
Dentsply Implants NV
Version 18.5
In Commercial Distribution

  • 07392532208416 ()
54500277V185

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532206269

Simplant Pro
Dentsply Implants NV
Version 18.5
In Commercial Distribution

  • 07392532206269 ()
54500277P185

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532205583

Case Viewer
Dentsply Implants NV
Version 3
In Commercial Distribution

  • 07392532205583 ()
54500395IV3

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532204814

Simplant Editor
Dentsply Implants NV
Version 3
In Commercial Distribution

  • 07392532204814 ()
54500394E3

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532191251

Simplant Pro
Dentsply Implants NV
Version 18
In Commercial Distribution

  • 07392532191251 ()
54500277P18

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532191237

Simplant OneShot
DENTSPLY IH, INC.
Version 18
Not in Commercial Distribution

  • 07392532191237 ()
54500277O18

  • Panoramic/tomographic dental x-ray system application software

Simplant - 07392532191220

Simplant View
Dentsply Implants NV
Version 18
In Commercial Distribution

  • 07392532191220 ()
54500277V18

  • Panoramic/tomographic dental x-ray system application software

SIMPLANT® - 07392532181276

SIMPLANT Viewer
Dentsply Implants NV
Version 2
Not in Commercial Distribution

  • 07392532181276 ()
54500395IV

  • Panoramic/tomographic dental x-ray system application software

SIMPLANT® - 07392532181252

SIMPLANT Editor
Dentsply Implants NV
Version 2
In Commercial Distribution

  • 07392532181252 ()
54500394E2

  • Panoramic/tomographic dental x-ray system application software

SIMPLANT® - 07392532178030

SIMPLANT Pro
Dentsply Implants NV
Version 17
Not in Commercial Distribution

  • 07392532178030 ()
54500277A

  • Panoramic/tomographic dental x-ray system application software

Head Support Mounting Hardware Multi-Straigt, Black - 04064406090245

No Description
Otto Bock Mobility Solutions GmbH
476L52=SK025
In Commercial Distribution

  • 04064406090245 ()


  • Wheelchair/chair/stander headrest

Head Support Mounting Hardware Multi-Crank, Black - 04064406090221

No Description
Otto Bock Mobility Solutions GmbH
476L52=SK015
In Commercial Distribution

  • 04064406090221 ()


  • Wheelchair/chair/stander headrest

PowerLook PRO+ Hardware Platform GE, US - 00850008977121

No Description
Icad, Inc.
DSC018-04
In Commercial Distribution

  • 00850008977121 ()


  • Radiology DICOM image processing application software

E2 Carbon Fiber Removable Hardware (set) - 07540147001346

E2 Carbon Fiber Removable Mounting Hardware (set); Removable mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Quick-release design. (Fits 3/4", 7/8" or 1" back cane diameters)
Motion Concepts Inc
CFQR
In Commercial Distribution

  • 07540147001346 ()
CFQR

  • Wheelchair back rest positioner

FLOORSTAND MOUNTING HARDWARE KIT, A SERIES - 00810040250545

No Description
GLOBAL SURGICAL CORPORATION
124-002-073
In Commercial Distribution

  • 00810040250545 ()


  • General-purpose surgical microscope

Brydan Medical - 00853301008295

Back w/armrest-padded full length for Stool, complete with hardware, - with uph back
BRYDAN MEDICAL HOLDINGS
90086
In Commercial Distribution

  • 00853301008295 ()


  • Chair/stool armrest

LABSYSTEM™ PRO - 08714729883678

VGA Image Capture Option Hardware Kit For LABSYSTEM™ PRO EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420019530
In Commercial Distribution

  • 08714729883678 ()


  • Multiple physiological signal amplifier

Axiom - 00840363368467

3 x 4 Lateral Pads with Fixed Mounting Hardware for BTX - Pair (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368467 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLF3X4PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368412

4 x 5 Lateral Pads with Fixed Mounting Hardware for BTX - Right (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368412 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLF4X5PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368405

3 x 4 Lateral Pads with Fixed Mounting Hardware for BTX - Right (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368405 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLF3X4PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368351

4 x 5 Lateral Pads with Fixed Mounting Hardware for BTX - Left (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368351 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLF4X5PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368344

3 x 4 Lateral Pads with Fixed Mounting Hardware for BTX - Left (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368344 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLF3X4PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368290

4 x 5 Lateral Pads with Fixed Mounting Hardware for BTX - Pair (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368290 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLF4X5PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368283

3 x 4 Lateral Pads with Fixed Mounting Hardware for BTX - Pair (E0956)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368283 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLF3X4PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368054

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368054 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368047

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368047 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLASC3x4R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368030

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368030 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368023

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368023 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3x4R

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367958

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367958 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLASC4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367941

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367941 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLASC3x4L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367934

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367934 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367927

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367927 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3x4L

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363367750

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367750 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLASC4x5L

  • Wheelchair head/trunk support, prefabricated
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