510k
Database
Specialties
Anesthesiology
516
Cardiovascular
1597
Chemistry
356
Dental
1292
Ear, Nose, Throat
234
Gastroenterology & Urology
924
General & Plastic Surgery
2123
General Hospital
1927
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
935
Obstetrics & Gynecology
425
Ophthalmic
269
Orthopedic
2686
Pathology
52
Physical Medicine
508
Radiology
2310
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
395
LLZ
System, Image Processing,...
364
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
315
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
272
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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Truvian Health
Medical Device Manufacturer
·
US , San Diego , CA
Truvian Health - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2025
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Truvian Health
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 09, 2026
Core Metabolic
K251157
·
CIX
Chemistry
·
269d
Cleared
Dec 30, 2025
Lipids
K251091
·
CHH
Chemistry
·
264d
Cleared
Dec 19, 2025
Tru Liver Health Test Panel
K251074
·
CJE
Chemistry
·
255d
Cleared
Nov 26, 2025
Tru Kidney Health Test Panel
K251058
·
CGX
Chemistry
·
236d
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4
Chemistry
4