510k
Database
Specialties
Anesthesiology
1091
Cardiovascular
4406
Chemistry
3258
Dental
2793
Ear, Nose, Throat
468
Gastroenterology & Urology
2416
General & Plastic Surgery
4110
General Hospital
3826
Hematology
805
Immunology
782
Medical Genetics
15
Microbiology
1726
Neurology
1765
Obstetrics & Gynecology
878
Ophthalmic
497
Orthopedic
7544
Pathology
166
Physical Medicine
963
Radiology
4665
Toxicology
1239
Categories
LLZ
System, Image Processing,...
729
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
520
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
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
CA
Xltek
Medical Device Manufacturer
·
CA , Oakville
Xltek - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Xltek
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 14, 2002
84 CHANNEL EEG
K014146
·
GWQ
Neurology
·
27d
Cleared
Jan 14, 2002
80 CHANNEL EEG
K014147
·
GWQ
Neurology
·
27d
Cleared
Dec 08, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969
·
GWF
Neurology
·
77d
Filters
Filter by Specialty
All
3
Neurology
3