510k
Database
Specialties
Anesthesiology
204
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739
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187
Dental
466
Ear, Nose, Throat
91
Gastroenterology & Urology
394
General & Plastic Surgery
774
General Hospital
475
Hematology
77
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64
Medical Genetics
1
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277
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301
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117
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79
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1477
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26
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152
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1092
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94
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
124
QIH
Automated Radiological Image...
111
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Embla Systems
Medical Device Manufacturer
·
US , Thornton , CO
Embla Systems - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2011
8
Total
8
Cleared
0
Denied
FDA 510(k) cleared devices by Embla Systems
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 13, 2017
Disposable Snap Electrode
K172703
·
GXY
Neurology
·
67d
Cleared
Apr 11, 2017
REMbrandt
K163617
·
OLZ
Neurology
·
110d
Cleared
Dec 01, 2016
RemLogic
K162140
·
OLZ
Neurology
·
122d
Cleared
Jun 23, 2016
SANDMAN ELITE
K153353
·
OLZ
Neurology
·
216d
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8
Anesthesiology
4
Neurology
4