510k
Database
Specialties
Anesthesiology
426
Cardiovascular
1287
Chemistry
325
Dental
984
Ear, Nose, Throat
184
Gastroenterology & Urology
757
General & Plastic Surgery
1659
General Hospital
1068
Hematology
116
Immunology
82
Medical Genetics
6
Microbiology
408
Neurology
725
Obstetrics & Gynecology
316
Ophthalmic
194
Orthopedic
2337
Pathology
44
Physical Medicine
390
Radiology
1876
Toxicology
139
Categories
GEX
Powered Laser Surgical Instrument
278
LLZ
System, Image Processing,...
262
QIH
Automated Radiological Image...
245
GEI
Electrosurgical, Cutting &...
230
HRS
Plate, Fixation, Bone
230
IYN
System, Imaging, Pulsed Doppler,...
230
OLO
Orthopedic Stereotaxic Instrument
191
NHA
Abutment, Implant, Dental,...
178
LZA
Polymer Patient Examination Glove
163
NKB
Thoracolumbosacral Pedicle Screw...
159
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Olympus America, Inc.
Medical Device Manufacturer
·
US , Lake Success , NY
Olympus America, Inc. - FDA 510(k) Cleared Devices
149 submissions
·
149 cleared
·
Since 1994
149
Total
149
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus America, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 18, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K973128
·
FOG
Anesthesiology
·
89d
Filters
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All
149
Gastroenterology & Urology
36
Chemistry
34
Immunology
19
Radiology
15
General & Plastic Surgery
14
Ear, Nose, Throat
13
Obstetrics & Gynecology
12
Orthopedic
2
Microbiology
1
Anesthesiology
1