510k
Database
Specialties
Anesthesiology
446
Cardiovascular
1360
Chemistry
333
Dental
1052
Ear, Nose, Throat
194
Gastroenterology & Urology
806
General & Plastic Surgery
1772
General Hospital
1201
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
419
Neurology
763
Obstetrics & Gynecology
334
Ophthalmic
210
Orthopedic
2418
Pathology
44
Physical Medicine
406
Radiology
1967
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
289
LLZ
System, Image Processing,...
281
GEI
Electrosurgical, Cutting &...
251
QIH
Automated Radiological Image...
250
IYN
System, Imaging, Pulsed Doppler,...
240
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
202
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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I.S.G. Technologies, Inc.
Medical Device Manufacturer
·
CA , Ontario L4v 1s8
I.S.G. Technologies, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1987
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - I.S.G. Technologies, Inc.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 21, 1999
SNN FLUORO NAVIGATION SYSTEM
K993673
·
HAW
Neurology
·
50d
Cleared
Jan 13, 1999
SNN SCOUT
K982570
·
HAW
Neurology
·
174d
Cleared
Jun 04, 1997
ISG FAMILY OF VIEWING WANDS
K970865
·
HAW
Neurology
·
86d
Cleared
May 29, 1996
ISG VIEWING WAND
K960714
·
HAW
Neurology
·
98d
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10
Radiology
6
Neurology
4