510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1672
Chemistry
364
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
969
General & Plastic Surgery
2190
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
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466
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965
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433
Ophthalmic
274
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2912
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52
Physical Medicine
515
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2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Faico Medical, LLC
Medical Device Manufacturer
·
US , Boca Raton , FL
Faico Medical, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Faico Medical, LLC
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 18, 2021
FAICO Dental Implant System and CAD/CAM Abutments
K211871
·
NHA
Dental
·
154d
Cleared
Apr 22, 2020
FAICO CMF System
K191997
·
JEY
Dental
·
271d
Cleared
Apr 03, 2020
Faico Dental Implant System
K192015
·
DZE
Dental
·
249d
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3
Dental
3