510k
Database
Specialties
Anesthesiology
411
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1252
Chemistry
309
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950
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181
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739
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1606
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995
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113
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80
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6
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402
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695
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303
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186
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2263
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43
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378
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1825
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138
Categories
GEX
Powered Laser Surgical Instrument
267
LLZ
System, Image Processing,...
255
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Automated Radiological Image...
237
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System, Imaging, Pulsed Doppler,...
225
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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LivaNova USA, Inc.
Medical Device Manufacturer
·
US , Arvada , CO
LivaNova USA, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - LivaNova USA, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 11, 2026
Venous Return Cannulae
K250937
·
DWF
Cardiovascular
·
348d
Cleared
Jul 10, 2025
RAP Femoral Venous Cannulae
K250283
·
DWF
Cardiovascular
·
160d
Cleared
Aug 08, 2024
SMARxT Tubing and Connectors
K233702
·
DWE
Cardiovascular
·
265d
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3
Cardiovascular
3