510k
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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
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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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CenterPoint Systems, LLC
Medical Device Manufacturer
·
US , West Valley City , UT
CenterPoint Systems, LLC - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2021
Official Website
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - CenterPoint Systems, LLC
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
May 02, 2024
Dragonfly™ Pancreaticobiliary Scope
K233752
·
FBN
Gastroenterology & Urology
·
162d
Cleared
Jul 31, 2023
RenaNav Ureteroscope System
K223097
·
FGB
Gastroenterology & Urology
·
304d
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12
Cardiovascular
10
Gastroenterology & Urology
2