Abbott
13 FDA 510(k) clearances · Manufacturer
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) | Abbott | 2026-07-02 |
| Amplatzer TorqVue Delivery System (K260993) | Abbott | 2026-04-24 |
| Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221) | Abbott | 2025-09-17 |
| Lingo Glucose System (K233655) | Abbott | 2024-05-29 |
| CentriMag Pre-connected Pack (K222297) | Abbott | 2022-12-01 |
| EnSite X EP System (K221213) | Abbott | 2022-08-18 |
| EnSite X EP System (K212061) | Abbott | 2021-10-22 |
| WorkMate Claris System (K210392) | Abbott | 2021-03-11 |
| Confirm Rx Insertable Cardiac Monitor (K192593) | Abbott | 2019-10-18 |
| MitraClip G4 Steerable Guide Catheter (K190167) | Abbott | 2019-05-29 |
| Confirm Rx Insertable Cardiac Monitor (K182981) | Abbott | 2019-03-29 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K183128) | Abbott | 2018-12-12 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644) | Abbott | 2018-10-19 |
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Every clearance here is in the API, with alerts when new ones post.