510k
Database
Specialties
Anesthesiology
1330
Cardiovascular
4923
Chemistry
3572
Dental
2814
Ear, Nose, Throat
475
Gastroenterology & Urology
2514
General & Plastic Surgery
4254
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3897
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873
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832
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15
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1930
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1841
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893
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498
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8086
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184
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978
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5179
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1295
Categories
LLZ
System, Image Processing,...
757
HRS
Plate, Fixation, Bone
696
IYN
System, Imaging, Pulsed Doppler,...
609
GEI
Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
HWC
Screw, Fixation, Bone
404
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Manufacturers
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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