510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2201
General Hospital
2052
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
472
Neurology
969
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2961
Pathology
52
Physical Medicine
515
Radiology
2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Olympus Surgical Technologies America
Medical Device Manufacturer
·
US , Southborough , MA
Olympus Surgical Technologies America - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2012
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus Surgical Technologies America
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 03, 2018
PeriView FLEX
K181193
·
KTI
Ear, Nose, Throat
·
60d
Cleared
Sep 21, 2017
PeriView FLEX
K171232
·
KTI
Ear, Nose, Throat
·
147d
Cleared
Apr 06, 2017
ViziShot 2 FLEX
K163469
·
KTI
Ear, Nose, Throat
·
115d
Filters
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All
12
Gastroenterology & Urology
6
Ear, Nose, Throat
3
General & Plastic Surgery
2
Anesthesiology
1