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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Paragon Medical
Medical Device Manufacturer
·
US , Pierceton , IN
Paragon Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Paragon Medical
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 13, 2019
Sonopet iQ Sterilization Tray
K190667
·
KCT
General Hospital
·
90d
Cleared
May 07, 2019
Stryker ChestShield Sterilization Tray System
K183701
·
KCT
General Hospital
·
127d
Cleared
Apr 18, 2018
Stryker Universal Select Sterilization Tray System
K173615
·
KCT
General Hospital
·
147d
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3
General Hospital
3