510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2126
General Hospital
1959
Hematology
126
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91
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8
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449
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938
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425
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271
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2691
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52
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511
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2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Mindset Medical, Inc.
Medical Device Manufacturer
·
US , Phoenix , AZ
Mindset Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mindset Medical, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
CT
May 30, 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078
·
QME
Cardiovascular
·
137d
Cleared
CT
Nov 18, 2024
Informed Vital Core Application (IVC App)
K241633
·
QME
Cardiovascular
·
165d
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Cardiovascular
2