510k
Database
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Anesthesiology
206
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741
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187
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472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
780
General Hospital
478
Hematology
77
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64
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1
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277
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309
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121
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81
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1481
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26
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155
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1101
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94
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IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
127
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Dornoch Medical Systems
Medical Device Manufacturer
·
US , Riverside , MO
Dornoch Medical Systems - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Dornoch Medical Systems
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 2019
IntelliCartTM System
K190789
·
JCX
General & Plastic Surgery
·
28d
Cleared
Sep 14, 2017
IntelliCart System
K172481
·
JCX
General & Plastic Surgery
·
29d
Cleared
Dec 21, 2016
IntelliCartTM System
K162421
·
JCX
General & Plastic Surgery
·
113d
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3
General & Plastic Surgery
3