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543
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537
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499
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Polymer Patient Examination Glove
490
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465
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448
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510k Database
Manufacturers
CH
Enbio Group AG
Medical Device Manufacturer
·
CH , Oensingen
Enbio Group AG - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
Recent clearances:
Enbio PRO
,
Enbio S
,
Enbio S
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
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3
General Hospital
3