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Abbott

13 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825)Abbott2026-07-02
Amplatzer TorqVue Delivery System (K260993)Abbott2026-04-24
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221)Abbott2025-09-17
Lingo Glucose System (K233655)Abbott2024-05-29
CentriMag Pre-connected Pack (K222297)Abbott2022-12-01
EnSite X EP System (K221213)Abbott2022-08-18
EnSite X EP System (K212061)Abbott2021-10-22
WorkMate Claris System (K210392)Abbott2021-03-11
Confirm Rx Insertable Cardiac Monitor (K192593)Abbott2019-10-18
MitraClip G4 Steerable Guide Catheter (K190167)Abbott2019-05-29
Confirm Rx Insertable Cardiac Monitor (K182981)Abbott2019-03-29
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K183128)Abbott2018-12-12
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644)Abbott2018-10-19

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Every clearance here is in the API, with alerts when new ones post.