510k
Database
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538
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1654
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360
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1323
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243
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957
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2175
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2038
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126
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97
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8
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462
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958
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Quibim S.L.
Medical Device Manufacturer
·
ES , Valencia
Quibim S.L. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Quibim S.L.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 18, 2025
QP-Prostate® CAD
K242683
·
QDQ
Radiology
·
193d
Cleared
Dec 13, 2023
QP-Brain®
K232231
·
QIH
Radiology
·
139d
Cleared
Feb 04, 2021
QUIBIM Precision Prostate (qp-Prostate)
K203582
·
LLZ
Radiology
·
59d
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3
Radiology
3