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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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DRGEM - 08800011140380

100-240V~ / 150kV
DRGEM Corporation
GXR-U32SD
In Commercial Distribution

  • 08800011140380 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140366

220-230V~ / 125kV
DRGEM Corporation
GXR-C52SD
In Commercial Distribution

  • 08800011140366 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140342

220-230V~ / 150kV
DRGEM Corporation
GXR-C40SD
In Commercial Distribution

  • 08800011140342 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140328

110-120V~ / 150kV
DRGEM Corporation
GXR-C40SD
In Commercial Distribution

  • 08800011140328 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140304

220-230V~ / 125kV
DRGEM Corporation
GXR-C32SD
In Commercial Distribution

  • 08800011140304 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140229

400V3~ / 125kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140229 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140205

480V3~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140205 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140182

400V3~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140182 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140175

*Line power rating: 480V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-8A
In Commercial Distribution

  • 08800011140175 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140144

100-240V~ / 125kV
DRGEM Corporation
GXR-U40SD
In Commercial Distribution

  • 08800011140144 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140120

110-120V~ / 125kV
DRGEM Corporation
GXR-C52SD
In Commercial Distribution

  • 08800011140120 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140090

400V3~ / 150kV
DRGEM Corporation
GXR-82SD
In Commercial Distribution

  • 08800011140090 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140076

400V3~ / 150kV
DRGEM Corporation
GXR-52SD
In Commercial Distribution

  • 08800011140076 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140052

220-230V~ / 125kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140052 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140038

220-230V~ / 125kV
DRGEM Corporation
GXR-32SD
In Commercial Distribution

  • 08800011140038 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140014

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-6A
In Commercial Distribution

  • 08800011140014 ()


  • Stationary basic diagnostic x-ray system, digital

3D X-Ray Tube mount - 04056869025209

X-Ray Tube mount
Siemens Healthcare GmbH
10501776
In Commercial Distribution

  • 04056869025209 ()


  • Stationary basic diagnostic x-ray system, digital

Multix DR-Upgrade KIT VA20 - 04056869019925

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893540
In Commercial Distribution

  • 04056869019925 ()


  • Stationary basic diagnostic x-ray system, digital

Multix DR-Upgrade KIT VA20 - 04056869019918

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893697
In Commercial Distribution

  • 04056869019918 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion VA40 - 04056869019901

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893300
In Commercial Distribution

  • 04056869019901 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion VA30 - 04056869019895

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10746667
In Commercial Distribution

  • 04056869019895 ()


  • Stationary basic diagnostic x-ray system, digital

Ysio Max - 04056869004273

Radiography System
Siemens Healthcare GmbH
10762470
In Commercial Distribution

  • 04056869004273 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact C - 04056869262147

No Description
Siemens Shanghai Medical Equipment Ltd.
11020896
In Commercial Distribution

  • 04056869262147 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact - 04056869226545

No Description
Siemens Shanghai Medical Equipment Ltd.
11020788
In Commercial Distribution

  • 04056869226545 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact E - 04056869951386

No Description
Siemens Shanghai Medical Equipment Ltd.
11333999
In Commercial Distribution

  • 04056869951386 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact - 04056869279985

No Description
Siemens Shanghai Medical Equipment Ltd.
11333888
In Commercial Distribution

  • 04056869279985 ()


  • Stationary basic diagnostic x-ray system, digital

YSIO X.pree - 04056869232904

No Description
Siemens Healthcare GmbH
11107464
In Commercial Distribution

  • 04056869232904 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion Max - 04056869050713

No Description
Siemens Shanghai Medical Equipment Ltd.
11020660
In Commercial Distribution

  • 04056869050713 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX SELECT DR - 04056869006925

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10569624
In Commercial Distribution

  • 04056869006925 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806095799643

The GF85 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.
GF85-SP
In Commercial Distribution

  • 08806095799643 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806095799636

The GF85 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.
GF85-3P
In Commercial Distribution

  • 08806095799636 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088670560

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

NA - 08806088566313

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

NA - 08806088565231

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

NA - 08806088520971

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

NA - 08806088351889

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

NA - 08806088351872

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

NA - 08806086403467

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

Recording Cap G1 - 08592566829345

82-934
DEYMED Diagnostic s.r.o.
L (23“ - 25“)
In Commercial Distribution

  • 08592566829345 ()
82-934

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566829338

82-933
DEYMED Diagnostic s.r.o.
M (21.5“ - 23“)
In Commercial Distribution

  • 08592566829338 ()
82-933

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566829321

82-932
DEYMED Diagnostic s.r.o.
S (20“ - 21.5“)
In Commercial Distribution

  • 08592566829321 ()
82-932

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566829314

82-931
DEYMED Diagnostic s.r.o.
XS (18.5“ - 20“)
In Commercial Distribution

  • 08592566829314 ()
82-931

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829178

Size L 59-63 cm, 23-25 in
DEYMED Diagnostic s.r.o.
Size L 59-63 cm, 23-25 in
In Commercial Distribution

  • 08592566829178 ()
82-917

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829161

Size M 55-59 cm, 21,5-23 in
DEYMED Diagnostic s.r.o.
Size M 55-59 cm, 21,5-23 in
In Commercial Distribution

  • 08592566829161 ()
82-916

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829154

Size S 51-55 cm, 20-21,5 in
DEYMED Diagnostic s.r.o.
Size S 51-55 cm, 20-21,5 in
In Commercial Distribution

  • 08592566829154 ()
82-915

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829147

Size XS 47-51 cm, 18,5-20 in
DEYMED Diagnostic s.r.o.
Size XS 47-51 cm, 18,5-20 in
In Commercial Distribution

  • 08592566829147 ()
82-914

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829130

82-913
DEYMED Diagnostic s.r.o.
Size L 59-63 cm, 23-25 in, layout 06
In Commercial Distribution

  • 08592566829130 ()
82-913

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829123

82-912
DEYMED Diagnostic s.r.o.
Size M 55-59 cm, 21,5-23 in, layout 06
In Commercial Distribution

  • 08592566829123 ()
82-912

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829116

82-911
DEYMED Diagnostic s.r.o.
Size S 51-55 cm, 20-21,5 in, layout 06
In Commercial Distribution

  • 08592566829116 ()
82-911

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829109

82-910
DEYMED Diagnostic s.r.o.
Size XS 47-51 cm, 18,5-20 in, layout 06
In Commercial Distribution

  • 08592566829109 ()
82-910

  • Psychophysiological biofeedback system
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