510k
Database
Specialties
Anesthesiology
331
Cardiovascular
1056
Chemistry
268
Dental
798
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1314
General Hospital
747
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
568
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2042
Pathology
38
Physical Medicine
309
Radiology
1577
Toxicology
131
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
209
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
198
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
154
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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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