510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1585
Chemistry
355
Dental
1279
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2111
General Hospital
1873
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
930
Obstetrics & Gynecology
421
Ophthalmic
267
Orthopedic
2681
Pathology
50
Physical Medicine
507
Radiology
2294
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
386
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
279
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Icu Medical
Medical Device Manufacturer
·
US , Lake Forest , IL
Icu Medical - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Icu Medical
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 20, 2020
Rio Vial-to-Bag Drug Reconstitution Device
K192154
·
LHI
General Hospital
·
255d
Cleared
Mar 06, 2020
SwabTip Male Disinfectant Cap
K190918
·
QBP
General Hospital
·
332d
Cleared
Oct 23, 2019
Diana ChemoClave Transfer Set
K190157
·
ONB
General Hospital
·
266d
Cleared
Aug 25, 2017
Sapphire Sets
K171346
·
MRZ
General Hospital
·
109d
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5
General Hospital
4
Cardiovascular
1