510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
973
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
279
Orthopedic
2934
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Opticon Medical, Inc.
Medical Device Manufacturer
·
US , Gurnee , IL
Opticon Medical, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1990
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Opticon Medical, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 26, 1993
WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
K904999
·
BSR
Anesthesiology
·
812d
Cleared
Feb 22, 1990
LOPER CELIAC PLEXUS BLOCK CATHETER KIT
K895955
·
CAZ
Anesthesiology
·
134d
Cleared
Jan 19, 1990
OPTION EPIDURAL CATHETERS
K895476
·
CAZ
Anesthesiology
·
130d
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7
Anesthesiology
3
Gastroenterology & Urology
3
Cardiovascular
1