510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2186
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2886
Pathology
52
Physical Medicine
515
Radiology
2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
Browse all 339 categories →
Search
Reports
Glossary
About
Home
Iradimed Corporation
Medical Device Manufacturer
·
US , Winter Park , FL
Iradimed Corporation - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2005
Official Website
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iradimed Corporation
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 29, 2019
3880 MRI Patient Monitoring System
K180903
·
MWI
Cardiovascular
·
357d
Cleared
Dec 14, 2018
3880 MRI Patient Monitoring System
K182900
·
MWI
Cardiovascular
·
59d
Cleared
Oct 25, 2017
3880 MRI Patient Monitoring System
K172200
·
MWI
Cardiovascular
·
96d
Filters
Filter by Specialty
All
7
General Hospital
4
Cardiovascular
3