510k
Database
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542
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1683
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370
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1341
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250
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979
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2201
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2052
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126
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99
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8
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472
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969
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436
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279
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2961
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52
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515
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2457
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Therenva Sas
Medical Device Manufacturer
·
FR , Rennes
Therenva Sas - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2014
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Therenva Sas
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 25, 2022
EndoNaut
K222070
·
OWB
Radiology
·
103d
Cleared
Aug 31, 2021
EndoNaut
K212383
·
OWB
Radiology
·
29d
Cleared
Sep 21, 2017
EndoNaut
K171829
·
OWB
Radiology
·
93d
Cleared
Apr 12, 2016
EndoSize
K160376
·
LLZ
Radiology
·
62d
Cleared
Jul 31, 2014
ENDOSIZE
K141475
·
LLZ
Radiology
·
57d
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5
Radiology
5