510k
Database
Specialties
Anesthesiology
474
Cardiovascular
1435
Chemistry
336
Dental
1131
Ear, Nose, Throat
210
Gastroenterology & Urology
839
General & Plastic Surgery
1891
General Hospital
1433
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
426
Neurology
811
Obstetrics & Gynecology
361
Ophthalmic
237
Orthopedic
2472
Pathology
49
Physical Medicine
437
Radiology
2060
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
276
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Clarus Medical Systems, Inc.
Medical Device Manufacturer
·
US , Minneapolis , MN
Clarus Medical Systems, Inc. - FDA 510(k) Cleared Devices
22 submissions
·
20 cleared
·
Since 1992
22
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Clarus Medical Systems, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 18, 1998
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
K980588
·
GAD
General & Plastic Surgery
·
182d
Cleared
Jun 01, 1993
CLARUS CHOLANGIOGRAM CATHETER KIT
K925742
·
GBZ
General & Plastic Surgery
·
200d
Cleared
Nov 16, 1992
CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
K922881
·
GEX
General & Plastic Surgery
·
153d
Filters
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All
22
Neurology
8
Orthopedic
4
Gastroenterology & Urology
3
General & Plastic Surgery
3
Ear, Nose, Throat
2
Cardiovascular
1
Ophthalmic
1