510k
Database
Specialties
Anesthesiology
529
Cardiovascular
1640
Chemistry
359
Dental
1314
Ear, Nose, Throat
239
Gastroenterology & Urology
950
General & Plastic Surgery
2164
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
461
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2804
Pathology
52
Physical Medicine
515
Radiology
2377
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
377
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
223
MAX
Intervertebral Fusion Device...
206
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Syngene, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Syngene, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1990
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syngene, Inc.
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 03, 1990
SNAP MYCOBACTERIA AVIUM COMPLEX
K900202
·
LQF
Microbiology
·
77d
Cleared
Apr 03, 1990
SNAP M. TUBERCULOSIS COMPLEX
K900292
·
LQF
Microbiology
·
71d
Filters
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2
Microbiology
2