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EDWARDS INTUITY ELITE AORTIC SIZER 21
Edwards Lifesciences LLC · Model 1183R · UDI-DI 00690103200232
DTI
Prescription
7
510(k) clearances
200
Adverse events
2
Recalls
22
Facilities
Description
Edwards Intuity Elite Valve System Aortic Sizer 21mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in conta |
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in conta |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.