510k
Database
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Anesthesiology
204
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737
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187
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465
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91
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393
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769
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475
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77
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64
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1
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277
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297
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116
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77
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1476
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26
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152
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1085
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Engage Uni, LLC
Medical Device Manufacturer
·
US , Winter Park , FL
Engage Uni, LLC - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2019
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Engage Uni, LLC
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 21, 2019
Engage™ Partial Knee System
K190439
·
NJD
Orthopedic
·
269d
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