510k
Database
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Anesthesiology
134
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569
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165
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318
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68
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290
General & Plastic Surgery
525
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377
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67
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57
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0
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234
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173
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62
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51
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1295
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18
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87
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872
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Wellysis Corp.
Medical Device Manufacturer
·
KR , Seoul
Wellysis Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Wellysis Corp.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 16, 2024
S-Patch (S-Patch ExL)
K233906
·
DSH
Cardiovascular
·
66d
Cleared
Aug 30, 2023
S-Patch Ex Wearable ECG Patch
K231289
·
DSH
Cardiovascular
·
118d
Filters
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Cardiovascular
2