510k
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134
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569
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165
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316
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68
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289
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522
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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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169
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62
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50
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1295
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18
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87
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871
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
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Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Biocardia
Medical Device Manufacturer
·
US , San Carlos , CA
Biocardia - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Biocardia
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 23, 2024
Morph DNA Steerable Introducer Sheath
K242169
·
DYB
Cardiovascular
·
30d
Cleared
Jan 07, 2020
BioCardia 8F Morph DNA Deflectable Guide Catheter
K192774
·
DQY
Cardiovascular
·
99d
Filters
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2
Cardiovascular
2