510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1708
Chemistry
379
Dental
1352
Ear, Nose, Throat
250
Gastroenterology & Urology
981
General & Plastic Surgery
2215
General Hospital
2066
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
439
Ophthalmic
282
Orthopedic
3008
Pathology
52
Physical Medicine
515
Radiology
2476
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
289
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
228
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Integrated Medical Systems, Inc.
Medical Device Manufacturer
·
US , Golden , CO
Integrated Medical Systems, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1987
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Integrated Medical Systems, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 26, 2008
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
K082256
·
MWI
Cardiovascular
·
49d
Cleared
May 28, 1987
IMS-2000S STRESS MONITOR
K871659
·
DXG
Cardiovascular
·
30d
Cleared
May 06, 1987
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K870934
·
DXG
Cardiovascular
·
58d
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5
Cardiovascular
3
Anesthesiology
1
General & Plastic Surgery
1