510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1627
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
944
General & Plastic Surgery
2151
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
946
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2764
Pathology
52
Physical Medicine
515
Radiology
2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Bistos Co., Ltd.
Medical Device Manufacturer
·
US , Flintville , TN
Bistos Co., Ltd. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2005
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bistos Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
May 28, 2021
Infant Phototherapy Equipment
K210289
·
LBI
General Hospital
·
115d
Cleared
Jul 03, 2014
INFANT INCUBATOR
K132543
·
FMZ
General Hospital
·
324d
Filters
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11
Obstetrics & Gynecology
6
General Hospital
2
Radiology
2
Neurology
1