510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1584
Chemistry
355
Dental
1274
Ear, Nose, Throat
233
Gastroenterology & Urology
922
General & Plastic Surgery
2110
General Hospital
1857
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
928
Obstetrics & Gynecology
420
Ophthalmic
266
Orthopedic
2678
Pathology
50
Physical Medicine
506
Radiology
2290
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
382
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
FXX
Mask, Surgical
270
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Gostar Co., Ltd.
Medical Device Manufacturer
·
TW , New Taipei City
Gostar Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gostar Co., Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 20, 2024
TD-7301 Spirometer (TD-7301)
K241843
·
BZG
Anesthesiology
·
147d
Cleared
Dec 19, 2023
TD-7301 Peak Flow meter
K222810
·
BZH
Anesthesiology
·
459d
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3
Anesthesiology
2
General & Plastic Surgery
1