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Simulus™

MEDTRONIC, INC. · Model 851PS · UDI-DI 00763000334352

DTI
7
510(k) clearances
200
Adverse events
2
Recalls
22
Facilities

Description

SEMI-RIGID SIZER 851PS CE

Recalls

DateFirmReason
2020-01-14Medtronic CoreValve LLCDemonstration 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
2020-01-14Medtronic CoreValve LLCDemonstration 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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Data 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.