510k
Database
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Anesthesiology
549
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1720
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385
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1376
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252
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982
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2218
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2088
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127
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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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2495
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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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Powered Laser Surgical Instrument
363
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359
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Electrosurgical, Cutting &...
308
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Fci (France Chirurgie Instrumentation) Sas
Medical Device Manufacturer
·
FR , Paris
Fci (France Chirurgie Instrumentation) Sas - FDA 510(k) Cleared Devic...
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fci (France Chirurgie Instrumentation) Sas
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 24, 2022
EZYPOR
K212741
·
HPZ
Ophthalmic
·
298d
Cleared
Jun 11, 2021
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
K203569
·
NCB
Ophthalmic
·
186d
Cleared
Mar 11, 2021
Ritleng®+ and Ritleng®+ PVP
K201892
·
OKS
Ophthalmic
·
246d
Cleared
Dec 18, 2020
LacriJet®
K201606
·
OKS
Ophthalmic
·
186d
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4
Ophthalmic
4