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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XIOS XG SUPREME USB S1 SENSOR REPLACEMENT KIT, 180cm (6FT)
SIRONA DENTAL, INC.
6404631
In Commercial Distribution

  • D76464046311 ()


  • Dental digital imaging sensor, intraoral
XIOS XG SUPREME USB S2 SENSOR SHIP KIT, 270cm (9FT)
SIRONA DENTAL, INC.
6402247
In Commercial Distribution

  • D76464022471 ()


  • Dental digital imaging sensor, intraoral
XIOS XG SUPREME USB S1 SENSOR SHIP KIT, 270cm (9FT)
SIRONA DENTAL, INC.
6402239
In Commercial Distribution

  • D76464022391 ()


  • Dental digital imaging sensor, intraoral
XIOS XG SUPREME USB S0 SENSOR SHIP KIT, 270cm (9FT)
SIRONA DENTAL, INC.
6402221
In Commercial Distribution

  • D76464022211 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/3.0 CABLE FOR DSO, 9'
SIRONA DENTAL, INC.
100008663
In Commercial Distribution

  • D764100008663 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR/3.0 CABLE FOR DSO, 6'
SIRONA DENTAL, INC.
100008662
In Commercial Distribution

  • D764100008662 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR/3.0 CABLE FOR DSO, 6'
SIRONA DENTAL, INC.
100008660
In Commercial Distribution

  • D764100008660 ()


  • Dental digital imaging sensor, intraoral
X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital
The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
ILLUMINA, INC.
20032573
In Commercial Distribution

  • 00816270020217 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC70
In Commercial Distribution

  • 08806088670560 ()


  • Stationary basic diagnostic x-ray system, digital
The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM85
In Commercial Distribution

  • 08806088582412 ()


  • Mobile basic diagnostic x-ray system, digital
The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A
In Commercial Distribution

  • 08806088566313 ()


  • Stationary basic diagnostic x-ray system, digital
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital
The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital
The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-32S
In Commercial Distribution

  • 08806088511153 ()


  • Mobile basic diagnostic x-ray system, digital
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital
The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital
The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital
SYRINGE LABELER
BECTON, DICKINSON AND COMPANY
516800
In Commercial Distribution

  • 00382905168000 ()
516800

  • Intravenous injection automated detection/documentation system processor/transmitter
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital
XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital
Value Fixed Table
GE Hualun Medical Systems Co., Ltd
VFTBL-1
In Commercial Distribution

  • 00195278713766 ()
VFTBL-1

  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand
GE Hualun Medical Systems Co., Ltd
VMWS-1
In Commercial Distribution

  • 00195278713759 ()
VMWS-1

  • Stationary basic diagnostic x-ray system, digital
Definium Pace Select system designated medical device
GE Hualun Medical Systems Co., Ltd
Pace Select
In Commercial Distribution

  • 00195278526892 ()
B2604CAB

  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
Navigate
In Commercial Distribution

  • 00195278003348 ()


  • Mobile basic diagnostic x-ray system, digital
Definium Pace Select ET System UDI
GE Hualun Medical Systems Co., Ltd
Pace Select ET
In Commercial Distribution

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Upgrade Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
NAVIGATE UPGRADE
In Commercial Distribution

  • 00195278798374 ()


  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system
Digital Medical X-ray Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i
In Commercial Distribution

  • 06971576833023 ()


  • Stationary basic diagnostic x-ray system, digital
The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution

  • 07350008750012 ()


  • Stationary basic diagnostic x-ray system, digital
Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution

  • 00823073061019 ()

  • Height: 244 Centimeter
  • Stand and Detector Head
  • Weight: 875 Kilogram


  • Stationary basic diagnostic x-ray system, digital
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2186BC-G
In Commercial Distribution

  • D0692186BCG0 ()


  • Dental delivery system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2186BC-C
In Commercial Distribution

  • D0692186BCC0 ()


  • Dental delivery system
BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC
MERCEDES MEDICAL, LLC
TNR CDOA262
In Commercial Distribution

  • 00850011007044 ()
  • 10850011007041 ()
  • 20850011007048 ()
TNR CDOA262

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
ALYON Series Spring Arm, Dual Flat Panel Monitor is used with the ALYON Suspension System
STERIS CORPORATION
ALYON Suspension System
In Commercial Distribution

  • 00724995222468 ()
LYS000005

  • Medical monitor/light mount
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