510k
Database
Specialties
Anesthesiology
133
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569
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164
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314
Ear, Nose, Throat
68
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288
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516
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373
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67
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56
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0
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233
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167
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61
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49
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1292
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18
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86
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870
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Medynus, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Medynus, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Medynus, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 03, 2022
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
K220379
·
KWQ
Orthopedic
·
21d
Cleared
Sep 23, 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792
·
ODP
Orthopedic
·
22d
Cleared
Apr 19, 2021
Goblin and Goblin LS Pedicle Screw Systems
K210420
·
NKB
Orthopedic
·
67d
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3
Orthopedic
3