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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HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600115 ()
2.0

  • Dental digital imaging sensor, intraoral
HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600108 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600092 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600085 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600078 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600061 ()
1.5

  • Dental digital imaging sensor, intraoral
No Description
NEUROLOGICA CORP.
GMR40
In Commercial Distribution

  • 10815411020298 ()


  • Computed radiography digital imaging scanner
CCD Detector
Imaging Dynamics Company Ltd
X3G
In Commercial Distribution

  • 00823073001046 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001039 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001022 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X4C
In Commercial Distribution

  • 00823073001015 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
HYDRA VISION DIGITAL IMAGING SYSTEM, 80KW SYSTEM
Liebel-Flarsheim Company LLC
705560
Not in Commercial Distribution

  • 10746190002826 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
HYDRA VISION DIGITAL IMAGING SYSTEM, 65KW SYSTEM
Liebel-Flarsheim Company LLC
705559
Not in Commercial Distribution

  • 10746190002819 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
Direct Digital Urology Imaging System, 80 kW
Liebel-Flarsheim Company LLC
700560
Not in Commercial Distribution

  • 10746190002475 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
Direct Digital Urology Imaging System, 64kW
Liebel-Flarsheim Company LLC
700559
Not in Commercial Distribution

  • 10746190002468 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
No Description
Ray Co., Ltd
RIO500 (size 2)
In Commercial Distribution

  • 08800003002023 ()


  • Dental digital imaging sensor, intraoral
No Description
Ray Co., Ltd
RIO500 (size 1)
In Commercial Distribution

  • 08800003002016 ()


  • Dental digital imaging sensor, intraoral
RADIOGRAPHIC RULER
AADCO MEDICAL, INC.
N-365
In Commercial Distribution

  • 00840348526387 ()
N-365

  • X-ray film ruler
R & L MARKERS 1" INITIAL
AADCO MEDICAL, INC.
N-223
In Commercial Distribution

  • 00840348526325 ()
N-223

  • Radiographic image marker, manual
THE GENERAL SET
AADCO MEDICAL, INC.
N-299
In Commercial Distribution

  • 00840348526370 ()
N-299

  • Radiographic image marker, manual
R & L POSITIONAL MARKERS
AADCO MEDICAL, INC.
N-225
In Commercial Distribution

  • 00840348526349 ()
N-225

  • Radiographic image marker, manual
HIGH KV COPPER SHIELDS W/ INITIALS
AADCO MEDICAL, INC.
N-224
In Commercial Distribution

  • 00840348526332 ()
N-224

  • Radiographic image marker, manual
LEAD MARKER R&L 1"
AADCO MEDICAL, INC.
N-221
In Commercial Distribution

  • 00840348526318 ()
N-221

  • Radiographic image marker, manual
ENGRAVED HOLDER FOR N-216
AADCO MEDICAL, INC.
N-216A
In Commercial Distribution

  • 00840348526301 ()
N-216A

  • Radiographic image marker, manual
MARKER SET W/ imprinted HOLDER 3/16" ON 5/8"
AADCO MEDICAL, INC.
N-216
In Commercial Distribution

  • 00840348526295 ()
N-216

  • Radiographic image marker, manual
POSITION INDICATOR x-RAY MARKERS W/ INITIALS
AADCO MEDICAL, INC.
N-215
In Commercial Distribution

  • 00840348526288 ()
N-215

  • Radiographic image marker, manual
POSITION INDICATOR X-RAY MARKERS
AADCO MEDICAL, INC.
N-214
In Commercial Distribution

  • 00840348526271 ()
N-214

  • Radiographic image marker, manual
UNIVERSAL LETTER/NO SET
AADCO MEDICAL, INC.
N-105
In Commercial Distribution

  • 00840348526264 ()
N-105

  • Radiographic image marker, manual
TOMOGRAPHIC NUMBER SET
AADCO MEDICAL, INC.
N-103
In Commercial Distribution

  • 00840348526257 ()
N-103

  • Full-body CT system
RADIOPAQUE 115cm RULER
AADCO MEDICAL, INC.
N-102
In Commercial Distribution

  • 00840348526240 ()
N-102

  • X-ray film ruler
X-RAY CALIPER
AADCO MEDICAL, INC.
N-101
In Commercial Distribution

  • 00840348526233 ()
N-101

  • Medical ruler, reusable
RADIOPAQUE 45 CM RULER
AADCO MEDICAL, INC.
N-100
In Commercial Distribution

  • 00840348526226 ()
N-100

  • X-ray film ruler
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343-TS
In Commercial Distribution

  • 08057737122361 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343 FL
In Commercial Distribution

  • 08057737122262 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343
In Commercial Distribution

  • 08057737122217 ()


  • Diagnostic x-ray digital imaging system workstation
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
CRF-CASSETTE-35X43-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CASCR3543
In Commercial Distribution

  • 00817100020476 ()


  • Digital imaging cassette
10X12 Cassette for CR Reader - R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CASCR2430
In Commercial Distribution

  • 00817100020469 ()


  • Digital imaging cassette
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution

  • 00817100020407 ()


  • Diagnostic x-ray digital imaging system workstation application software
CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CRII60
In Commercial Distribution

  • 00817100020391 ()


  • Digital imaging cassette/phosphor plate
AF CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CR30
In Commercial Distribution

  • 00817100020360 ()


  • Digital imaging cassette/phosphor plate
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-02-01-000
In Commercial Distribution

  • 00817100020179 ()


  • Diagnostic x-ray digital imaging system workstation application software
LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software
VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

  • Computed radiography digital imaging scanner
VITA LE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner
Elite CR System W/WP
CARESTREAM HEALTH, INC.
Elite CR System
Not in Commercial Distribution

  • 60889978981311 ()
8981318

  • Computed radiography digital imaging scanner
Classic CR System
CARESTREAM HEALTH, INC.
Classic CR System
In Commercial Distribution

  • 60889978113613 ()
8113615

  • Computed radiography digital imaging scanner
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