510k
Database
Specialties
Anesthesiology
464
Cardiovascular
1403
Chemistry
334
Dental
1094
Ear, Nose, Throat
202
Gastroenterology & Urology
827
General & Plastic Surgery
1840
General Hospital
1313
Hematology
124
Immunology
86
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7
Microbiology
420
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787
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351
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222
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2449
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47
Physical Medicine
420
Radiology
2024
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
230
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
170
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Otsuka Electronics
Medical Device Manufacturer
·
US , Fort Collins , CO
Otsuka Electronics - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1992
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Otsuka Electronics
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 02, 1993
OE 1.5 SI
K925858
·
LNH
Radiology
·
380d
Cleared
Jul 10, 1992
MRI OE 1.5 SI
K920543
·
LNH
Radiology
·
156d
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2
Radiology
2