510k
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542
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1680
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365
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1337
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248
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972
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2194
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2047
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126
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99
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8
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469
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965
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433
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275
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2923
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52
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515
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2442
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
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System, Imaging, Pulsed Doppler,...
299
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Cequr SA
Medical Device Manufacturer
·
CH , Horw Luzern
Cequr SA - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cequr SA
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 10, 2026
CeQur Simplicity™ On-Demand Insulin Delivery System
K252757
·
OPP
Chemistry
·
224d
Cleared
Nov 13, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273
·
OPP
Chemistry
·
28d
Cleared
Jan 18, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447
·
OPP
Chemistry
·
91d
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3
Chemistry
3