510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
364
Dental
1337
Ear, Nose, Throat
245
Gastroenterology & Urology
971
General & Plastic Surgery
2191
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2922
Pathology
52
Physical Medicine
515
Radiology
2436
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
303
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Unimax Medical Systems, Inc.
Medical Device Manufacturer
·
TW , Taipei County
Unimax Medical Systems, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2011
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unimax Medical Systems, Inc.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 09, 2011
UNIMAX ANTI-FOG SOLUTION
K111622
·
OCT
Gastroenterology & Urology
·
91d
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7
General & Plastic Surgery
5
Gastroenterology & Urology
1
Obstetrics & Gynecology
1