510k
Database
Specialties
Anesthesiology
1012
Cardiovascular
4313
Chemistry
3201
Dental
2737
Ear, Nose, Throat
464
Gastroenterology & Urology
2290
General & Plastic Surgery
3915
General Hospital
3554
Hematology
778
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1750
Obstetrics & Gynecology
853
Ophthalmic
492
Orthopedic
7492
Pathology
163
Physical Medicine
958
Radiology
4597
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
555
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
453
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Bionike, Inc.
Medical Device Manufacturer
·
US , South San Francisco , CA
Bionike, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1997
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionike, Inc.
Toxicology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 28, 1999
BIONIKE AQ BARBITURATE TEST
K990280
·
DIS
Toxicology
·
151d
Filters
Filter by Specialty
All
2
Chemistry
1
Toxicology
1