510k
Database
Specialties
Anesthesiology
338
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1074
Chemistry
272
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826
Ear, Nose, Throat
149
Gastroenterology & Urology
638
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1338
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773
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100
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72
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1
Microbiology
368
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589
Obstetrics & Gynecology
249
Ophthalmic
156
Orthopedic
2064
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40
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312
Radiology
1596
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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Baylis Medical Company, Inc.
Medical Device Manufacturer
·
CA , Mississauga, Ontario
Baylis Medical Company, Inc. - FDA 510(k) Cleared Devices
24 submissions
·
24 cleared
·
Since 2012
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baylis Medical Company, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 26, 2016
PORTAGE System
K161878
·
HRX
Orthopedic
·
80d
Filters
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24
Cardiovascular
16
General & Plastic Surgery
6
Orthopedic
1
Neurology
1