510k
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430
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1306
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327
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1008
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190
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782
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1699
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1106
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117
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83
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7
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412
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734
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321
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199
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2367
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44
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393
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1901
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141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
240
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Plate, Fixation, Bone
232
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System, Imaging, Pulsed Doppler,...
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
171
NKB
Thoracolumbosacral Pedicle Screw...
161
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S.A.I.E.P. S.R.L.
Medical Device Manufacturer
·
US , Weatherford , OK
S.A.I.E.P. S.R.L. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2003
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - S.A.I.E.P. S.R.L.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
K023801
·
IXW
Radiology
·
90d
Cleared
Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825
·
IXW
Radiology
·
90d
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Radiology
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