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.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 18, 1998
PERCSCOPE MODEL 2600
K974579
·
HRX
Orthopedic
·
72d
Cleared
Apr 25, 1995
CLARUS PHOENIX ENDOSCOPE
K940144
·
HRX
Orthopedic
·
469d
Cleared
Apr 25, 1995
CLARUS NEURO ENDOSCOPE (MODEL 2230)
K941188
·
HRX
Orthopedic
·
407d
Cleared
Jan 07, 1994
CLARUS SERIES 2100 ENDOSCOPE
K923514
·
HRX
Orthopedic
·
540d
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