510k
Database
Specialties
Anesthesiology
379
Cardiovascular
1185
Chemistry
288
Dental
879
Ear, Nose, Throat
163
Gastroenterology & Urology
693
General & Plastic Surgery
1491
General Hospital
879
Hematology
108
Immunology
77
Medical Genetics
1
Microbiology
387
Neurology
647
Obstetrics & Gynecology
274
Ophthalmic
172
Orthopedic
2175
Pathology
41
Physical Medicine
352
Radiology
1728
Toxicology
136
Categories
GEX
Powered Laser Surgical Instrument
251
QIH
Automated Radiological Image...
228
LLZ
System, Image Processing,...
223
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
208
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
Browse all 339 categories →
Search
Reports
About
Home
First Sense Medical, LLC
Medical Device Manufacturer
·
US , Pontiac , MI
First Sense Medical, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - First Sense Medical, LLC
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 09, 2017
Sentinel BreastScan II System
K162767
·
LHQ
Radiology
·
101d
Cleared
Jun 01, 2016
FirstSense Breast Exam
K160573
·
LHQ
Radiology
·
93d
Filters
Filter by Specialty
All
2
Radiology
2