510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Icu Medical, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Icu Medical, Inc. - FDA 510(k) Cleared Devices
64 submissions
·
63 cleared
·
Since 1984
64
Total
63
Cleared
0
Denied
53
devices
51-53 of 53
Filters
1
2
3
Cleared
May 06, 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781
·
FMI
General Hospital
·
64d
Cleared
Aug 16, 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275
·
FMG
General Hospital
·
11d
Cleared
Mar 06, 1984
LOPEZ LOCK
K840273
·
FPA
General Hospital
·
43d
1
2
3
Filters
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All
64
General Hospital
53
Gastroenterology & Urology
5
Cardiovascular
5
Chemistry
1