510k
Database
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Anesthesiology
545
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1693
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370
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1348
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250
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979
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2206
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2053
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126
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100
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8
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473
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980
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438
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280
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2978
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52
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515
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2466
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
398
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Mask, Surgical
358
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Powered Laser Surgical Instrument
358
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Termosalud
Medical Device Manufacturer
·
ES , Gijon
Termosalud - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2023
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Termosalud
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 12, 2024
Eneka Selectif
K241656
·
GEX
General & Plastic Surgery
·
63d
Cleared
Jun 08, 2023
Zionic Aesthetic
K230659
·
PBX
General & Plastic Surgery
·
91d
Cleared
Apr 13, 2023
Symmed Elite Aesthetic
K230412
·
PBX
General & Plastic Surgery
·
57d
Cleared
Feb 10, 2023
Eneka Pro
K223680
·
GEX
General & Plastic Surgery
·
64d
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5
General & Plastic Surgery
4
Physical Medicine
1