510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
364
Dental
1337
Ear, Nose, Throat
245
Gastroenterology & Urology
971
General & Plastic Surgery
2191
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2922
Pathology
52
Physical Medicine
515
Radiology
2436
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
303
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
Browse all 339 categories →
Search
Reports
Glossary
About
Home
Philips Medical Systems B.V.
Medical Device Manufacturer
·
NL , Best
Philips Medical Systems B.V. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Philips Medical Systems B.V.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 16, 2026
Azurion R3.1
K254186
·
OWB
Radiology
·
24d
Cleared
Oct 24, 2025
Azurion R3.1
K251827
·
OWB
Radiology
·
133d
Filters
Filter by Specialty
All
2
Radiology
2