510k
Database
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Anesthesiology
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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Mask, Surgical
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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Enbio Group AG
Medical Device Manufacturer
·
CH , Oensingen
Enbio Group AG - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Enbio Group AG
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 26, 2026
Enbio PRO
K260254
·
FLE
General Hospital
·
30d
Cleared
Feb 22, 2022
Enbio S
K213991
·
FLE
General Hospital
·
63d
Cleared
Oct 29, 2021
Enbio S
K210279
·
FLE
General Hospital
·
270d
Filters
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3
General Hospital
3