510k
Database
Specialties
Anesthesiology
434
Cardiovascular
1319
Chemistry
327
Dental
1015
Ear, Nose, Throat
192
Gastroenterology & Urology
786
General & Plastic Surgery
1724
General Hospital
1120
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
413
Neurology
737
Obstetrics & Gynecology
324
Ophthalmic
200
Orthopedic
2379
Pathology
44
Physical Medicine
395
Radiology
1914
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
283
LLZ
System, Image Processing,...
270
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
234
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
165
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Baylis Medical Co., Inc.
Medical Device Manufacturer
·
CA , Mississauga
Baylis Medical Co., Inc. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1998
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baylis Medical Co., Inc.
Immunology
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 22, 2002
TORFLEX TRANSSEPTAL GUIDING SHEATH
K013919
·
DBY
Immunology
·
87d
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28
Cardiovascular
10
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9
General & Plastic Surgery
6
General Hospital
1
Orthopedic
1
Immunology
1