510k
Database
Specialties
Anesthesiology
139
Cardiovascular
574
Chemistry
166
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
530
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
64
Ophthalmic
51
Orthopedic
1298
Pathology
18
Physical Medicine
88
Radiology
880
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Blue Sky Bio, LLC
Medical Device Manufacturer
·
US , Grayslake , IL
Blue Sky Bio, LLC - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 2005
16
Total
16
Cleared
0
Denied
FDA 510(k) cleared devices by Blue Sky Bio, LLC
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 22, 2009
BLUE SKY BIO PLAN, VERSION .38
K090607
·
LLZ
Radiology
·
47d
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16
Dental
15
Radiology
1