510k
Database
Specialties
Anesthesiology
534
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1649
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359
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1323
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243
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956
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2174
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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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954
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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
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Therapanacea Sas
Medical Device Manufacturer
·
FR , Paris
Therapanacea Sas - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Therapanacea Sas
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 23, 2025
ART-Plan+ (v3.1.0)
K253091
·
MUJ
Radiology
·
91d
Cleared
Feb 25, 2025
ART-Plan+ (v.3.0.0)
K242822
·
MUJ
Radiology
·
160d
Cleared
Apr 22, 2024
ART-Plan (v.2.2.0)
K234068
·
MUJ
Radiology
·
122d
Cleared
Apr 19, 2023
ART-Plan
K230023
·
QKB
Radiology
·
105d
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4
Radiology
4