510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
958
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 &...
301
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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About
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Synaptive Medical, Inc.
Medical Device Manufacturer
·
CA , Toronto On
Synaptive Medical, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2014
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synaptive Medical, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 11, 2023
Synq Software Version 1.3
K232981
·
LNH
Radiology
·
20d
Cleared
Apr 29, 2020
Evry
K200327
·
LNH
Radiology
·
79d
Cleared
Mar 09, 2018
BrightMatter Plan 1.6.0
K180394
·
LLZ
Radiology
·
24d
Cleared
Mar 29, 2016
Synaptive ImageDrive Pro
K153284
·
LLZ
Radiology
·
138d
Cleared
Jun 02, 2014
BRIGHTMATTER PLANNING SOFTWARE
K140337
·
LLZ
Radiology
·
112d
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5