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1960
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12336
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1352
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1168
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1133
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933
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818
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794
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787
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740
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706
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675
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Endius, Inc.
Medical Device Manufacturer
·
US , Plainville , MA
Endius, Inc. - FDA 510(k) Cleared Devices
33 submissions
·
33 cleared
·
Since 1997
33
Total
33
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Feb 16, 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425
·
HRX
Orthopedic
·
48d
Cleared
Aug 13, 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794
·
HRX
Orthopedic
·
79d
Cleared
Feb 24, 1999
FLEXPOSURE RETRACTOR
K983144
·
HRX
Orthopedic
·
169d
1
2
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33
Orthopedic
28
General & Plastic Surgery
2
Gastroenterology & Urology
1
Ear, Nose, Throat
1
Neurology
1