510k
Database
Specialties
Anesthesiology
535
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2174
General Hospital
2038
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126
Immunology
97
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8
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462
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958
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433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Regulatory Insight, Inc.
Medical Device Manufacturer
·
US , Littleton , CO
Regulatory Insight, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Regulatory Insight, Inc.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
K140780
·
HIR
Gastroenterology & Urology
·
166d
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4
Physical Medicine
2
Gastroenterology & Urology
1
General & Plastic Surgery
1