510k
Database
Specialties
Anesthesiology
444
Cardiovascular
1352
Chemistry
331
Dental
1050
Ear, Nose, Throat
194
Gastroenterology & Urology
803
General & Plastic Surgery
1767
General Hospital
1193
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
418
Neurology
760
Obstetrics & Gynecology
332
Ophthalmic
208
Orthopedic
2415
Pathology
44
Physical Medicine
405
Radiology
1958
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
279
GEI
Electrosurgical, Cutting &...
250
QIH
Automated Radiological Image...
249
IYN
System, Imaging, Pulsed Doppler,...
238
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
199
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
NKB
Thoracolumbosacral Pedicle Screw...
167
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Olympus Optical, Co.
Medical Device Manufacturer
·
US , Great Neck, , NY
Olympus Optical, Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1996
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus Optical, Co.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
K971340
·
GWG
Neurology
·
475d
Cleared
Nov 29, 1996
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
K962952
·
LBK
Neurology
·
122d
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4
Neurology
2
Radiology
1
Gastroenterology & Urology
1