510k
Database
Specialties
Anesthesiology
130
Cardiovascular
566
Chemistry
162
Dental
310
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
512
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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