510k
Database
Specialties
Anesthesiology
332
Cardiovascular
1060
Chemistry
268
Dental
801
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1318
General Hospital
748
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
573
Obstetrics & Gynecology
243
Ophthalmic
155
Orthopedic
2045
Pathology
39
Physical Medicine
309
Radiology
1580
Toxicology
132
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,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
155
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Mitek Surgical Products, Inc.
Medical Device Manufacturer
·
US , Dedham , MA
Mitek Surgical Products, Inc. - FDA 510(k) Cleared Devices
31 submissions
·
26 cleared
·
Since 1989
31
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mitek Surgical Products, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 31, 1995
MITEK MINI ANCHOR
K936311
·
MNV
Gastroenterology & Urology
·
559d
Cleared
Oct 24, 1995
MITEK ABSORBABLE ANCHOR
K941599
·
MNV
Gastroenterology & Urology
·
571d
Cleared
Aug 02, 1995
ABSORBALBE ANCHOR
K944051
·
MNV
Gastroenterology & Urology
·
348d
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31
Orthopedic
21
General & Plastic Surgery
6
Gastroenterology & Urology
3
General Hospital
1