510k
Database
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Anesthesiology
525
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1612
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356
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1304
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235
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928
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2135
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1991
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126
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91
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8
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449
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942
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429
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272
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2704
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52
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515
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2334
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155
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LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
370
FXX
Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
266
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Edwards Lifesciences
Medical Device Manufacturer
·
US , Irvine , CA
Edwards Lifesciences - FDA 510(k) Cleared Devices
20 submissions
·
19 cleared
·
Since 2011
Official Website
20
Total
19
Cleared
1
Denied
FDA 510(k) Regulatory Record - Edwards Lifesciences
Neurology
✕
1
devices
1-1 of 1
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Cleared
Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
K240596
·
MUD
Neurology
·
226d
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20
Cardiovascular
19
Neurology
1