510k
Database
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Anesthesiology
548
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1719
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381
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1367
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252
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982
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2217
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2088
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126
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101
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8
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474
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980
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441
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283
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3046
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52
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515
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2492
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155
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LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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363
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359
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Smart Solutions Technologies SL
Medical Device Manufacturer
·
ES , Madrid
Smart Solutions Technologies SL - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smart Solutions Technologies SL
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 01, 2023
Nuubo Smart
K231620
·
DQK
Cardiovascular
·
60d
Cleared
Aug 03, 2018
ECG recorder and Arrhythmia Detector
K173461
·
DSH
Cardiovascular
·
269d
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Cardiovascular
2