510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Bose Corporation
Medical Device Manufacturer
·
US , Framingham , MA
Bose Corporation - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2018
Official Website
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Bose Corporation
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
May 05, 2021
Bose SoundControl Hearing Aids
K211008
·
QDD
Ear, Nose, Throat
·
30d
Not Cleared
Oct 05, 2018
Bose Hearing Aid
DEN180026
·
QDD
Ear, Nose, Throat
·
147d
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Ear, Nose, Throat
2