510k
Database
Specialties
Anesthesiology
430
Cardiovascular
1306
Chemistry
327
Dental
1008
Ear, Nose, Throat
190
Gastroenterology & Urology
782
General & Plastic Surgery
1699
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1106
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117
Immunology
83
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7
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412
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734
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321
Ophthalmic
199
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2367
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44
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393
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1901
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
240
IYN
System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
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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Nicolet Biomedical
Medical Device Manufacturer
·
US , Golden , CO
Nicolet Biomedical - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1998
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nicolet Biomedical
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 30, 2000
NICOLET VASOGUARD
K002766
·
JOP
Cardiovascular
·
86d
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8
Radiology
5
Cardiovascular
1
Obstetrics & Gynecology
1
Ear, Nose, Throat
1