510k
Database
Specialties
Anesthesiology
544
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1689
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370
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1347
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250
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979
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2204
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2052
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126
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100
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8
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472
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975
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437
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280
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2977
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52
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515
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2463
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Adas3D Medical S.L.
Medical Device Manufacturer
·
ES , Barcelona
Adas3D Medical S.L. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Adas3D Medical S.L.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 09, 2024
ADAS 3D
K240791
·
QIH
Radiology
·
171d
Cleared
May 23, 2023
ADAS 3D
K230803
·
LLZ
Radiology
·
61d
Cleared
Sep 03, 2021
ADAS 3D
K212421
·
LLZ
Radiology
·
30d
Cleared
Apr 05, 2021
ADAS 3D
K210850
·
LLZ
Radiology
·
14d
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4
Radiology
4