510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1584
Chemistry
355
Dental
1274
Ear, Nose, Throat
233
Gastroenterology & Urology
922
General & Plastic Surgery
2109
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1856
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126
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91
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8
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449
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926
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420
Ophthalmic
266
Orthopedic
2678
Pathology
50
Physical Medicine
506
Radiology
2290
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
381
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
270
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Baylis Medical Technologies, Inc.
Medical Device Manufacturer
·
CA , Mississauga
Baylis Medical Technologies, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
3 cleared
·
Since 2023
5
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baylis Medical Technologies, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 28, 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275
·
GEI
General & Plastic Surgery
·
270d
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5
Cardiovascular
4
General & Plastic Surgery
1