510k
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400
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1211
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302
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911
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173
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716
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1547
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112
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79
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395
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292
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2202
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42
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361
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1779
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137
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GEX
Powered Laser Surgical Instrument
253
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System, Image Processing,...
238
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
222
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Electrosurgical, Cutting &...
218
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Swissray Medical AG
Medical Device Manufacturer
·
US , Elizabeth , NJ
Swissray Medical AG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2005
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Swissray Medical AG
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314
·
MQB
Radiology
·
49d
Cleared
Dec 07, 2012
DDRVERSA MOTION
K123005
·
MQB
Radiology
·
71d
Cleared
Aug 23, 2011
DDRELEMENT
K110828
·
KPR
Radiology
·
152d
Cleared
Dec 15, 2005
DDRFORMULA AND DDRFORMULA PLUS
K052943
·
KPR
Radiology
·
56d
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4
Radiology
4