510k
Database
Specialties
Anesthesiology
547
Cardiovascular
1716
Chemistry
380
Dental
1358
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2217
General Hospital
2088
Hematology
126
Immunology
101
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
283
Orthopedic
3044
Pathology
52
Physical Medicine
515
Radiology
2492
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
296
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
232
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Cardiovascular Devices, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Cardiovascular Devices, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1982
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiovascular Devices, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 30, 1989
CDI(R) 2000 BLOOD GAS MONITOR
K884228
·
CBZ
Anesthesiology
·
115d
Cleared
Jan 10, 1985
INTRAVASCULAR BLOOD GAS SYSTEM
K843912
·
CCE
Anesthesiology
·
99d
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8
Cardiovascular
5
Anesthesiology
2
Toxicology
1