510k
Database
Specialties
Anesthesiology
1012
Cardiovascular
4311
Chemistry
3201
Dental
2736
Ear, Nose, Throat
464
Gastroenterology & Urology
2287
General & Plastic Surgery
3873
General Hospital
3553
Hematology
778
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1715
Obstetrics & Gynecology
849
Ophthalmic
492
Orthopedic
7382
Pathology
163
Physical Medicine
958
Radiology
4597
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
687
GEI
Electrosurgical, Cutting &...
545
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
444
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
387
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Manufacturers
US
Mitek Products
Medical Device Manufacturer
·
US , Westwood , MA
Mitek Products - FDA 510(k) Cleared Devices
30 submissions
·
30 cleared
·
Since 1996
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mitek Products
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 29, 1999
RESOLVE QUICKANCHOR
K993575
·
DZL
Dental
·
69d
Cleared
Dec 16, 1999
TALON ANCHOR SNAP-PAK
K993327
·
DZL
Dental
·
73d
Cleared
Nov 02, 1999
MITEK MINI ANCHOR
K992623
·
DZL
Dental
·
89d
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30
Orthopedic
22
General & Plastic Surgery
5
Dental
3