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Results for “Amulet™”
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EUDAMED
13
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2
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1
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9
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25 devices found
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Amplatzer™ Amulet™ 9-ACP2-010-028
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
Amulet™ STRBL-14F-075
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
Amulet™ Steerable Delivery Sheath
Abbott Medical
·
,
Ireland
Class II
FDA 510(k)
K232690
Active
Cleared 29 Sep 2023
Active
510(k)
510(k)
II
2 variants
Amulet™ Steerable Delivery Sheath
K250426
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Open recall
Abbott Medical
·
,
Ireland
Class III
FDA PMA
P200049
Active
Approved 14 Aug 2021
Active
PMA
PMA
III
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