510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2179
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
464
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Siemens Healthineers AG
Medical Device Manufacturer
·
DE , Forchheim
Siemens Healthineers AG - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2025
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthineers AG
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 15, 2026
BIOGRAPH One
K253023
·
OUO
Radiology
·
118d
Cleared
Nov 20, 2025
syngo.MR Applications (VB80)
K253495
·
LLZ
Radiology
·
23d
Cleared
Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059
·
QIH
Radiology
·
203d
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3
Radiology
3