510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1329
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2182
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
464
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2862
Pathology
52
Physical Medicine
515
Radiology
2418
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Biolase, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Biolase, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2014
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biolase, Inc.
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 22, 2021
EdgePro
K213428
·
NVK
Dental
·
62d
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10
General & Plastic Surgery
9
Dental
1