510k
Database
Specialties
Anesthesiology
532
Cardiovascular
1643
Chemistry
359
Dental
1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
952
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Dyansys, Inc.
Medical Device Manufacturer
·
US , Orinda , CA
Dyansys, Inc. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 2007
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dyansys, Inc.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 08, 2009
ECSCOPE 200
K091397
·
DPS
Cardiovascular
·
57d
Cleared
May 28, 2009
ECSCOPE 100
K091358
·
DPS
Cardiovascular
·
20d
Cleared
Jan 16, 2008
PORTABLE ECSCOPE 12I
K080036
·
DPS
Cardiovascular
·
9d
Cleared
Aug 31, 2007
THE PORTABLE ANSISCOPE
K071168
·
DPS
Cardiovascular
·
126d
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14
Neurology
10
Cardiovascular
4