510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1687
Chemistry
370
Dental
1347
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2204
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
975
Obstetrics & Gynecology
437
Ophthalmic
279
Orthopedic
2974
Pathology
52
Physical Medicine
515
Radiology
2463
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
Browse all 339 categories →
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Cook Biotech Incorporated
Medical Device Manufacturer
·
US , West Lafayetta , IN
Cook Biotech Incorporated - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 2013
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook Biotech Incorporated
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 31, 2016
AxoGuard Nerve Connector
K162741
·
JXI
Neurology
·
31d
Cleared
Jan 10, 2014
NERVE CUFF
K132660
·
JXI
Neurology
·
137d
Filters
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All
16
General & Plastic Surgery
10
Ear, Nose, Throat
2
Neurology
2
Obstetrics & Gynecology
1
Dental
1