510k
Database
Specialties
Anesthesiology
501
Cardiovascular
1556
Chemistry
354
Dental
1232
Ear, Nose, Throat
227
Gastroenterology & Urology
902
General & Plastic Surgery
2056
General Hospital
1655
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
441
Neurology
900
Obstetrics & Gynecology
403
Ophthalmic
262
Orthopedic
2648
Pathology
49
Physical Medicine
490
Radiology
2240
Toxicology
154
Categories
LLZ
System, Image Processing,...
339
GEX
Powered Laser Surgical Instrument
338
LZA
Polymer Patient Examination Glove
326
GEI
Electrosurgical, Cutting &...
288
QIH
Automated Radiological Image...
270
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
259
OLO
Orthopedic Stereotaxic Instrument
216
NHA
Abutment, Implant, Dental,...
204
MAX
Intervertebral Fusion Device...
193
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Nonin Medical, Inc.
Medical Device Manufacturer
·
US , White Bear Lake , MN
Nonin Medical, Inc. - FDA 510(k) Cleared Devices
50 submissions
·
50 cleared
·
Since 1986
50
Total
50
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nonin Medical, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model...
K190560
·
MUD
General & Plastic Surgery
·
58d
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50
Anesthesiology
44
Cardiovascular
5
General & Plastic Surgery
1