510k
Database
Specialties
Anesthesiology
132
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568
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162
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313
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68
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287
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513
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370
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67
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56
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0
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232
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163
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61
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49
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1289
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
99
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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Brightheart
Medical Device Manufacturer
·
FR , Paris
Brightheart - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2024
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Brightheart
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 08, 2025
Fetal EchoScan (v1.2)
K252294
·
POK
Radiology
·
138d
Cleared
Jun 05, 2025
BrightHeart View Classifier
K251456
·
QIH
Radiology
·
24d
Cleared
May 07, 2025
BrightHeart View Classifier
K243684
·
QIH
Radiology
·
159d
Cleared
May 02, 2025
Fetal EchoScan (v1.1)
K251071
·
POK
Radiology
·
25d
Cleared
Nov 14, 2024
Fetal EchoScan
K242342
·
POK
Radiology
·
99d
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Radiology
5