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The OZAKI AVPro Sizer Set
TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K. · Model TC-OZA-USC0YN · UDI-DI 04570057304292
DTI
Prescription
7
510(k) clearances
202
Adverse events
2
Recalls
22
Facilities
Description
Circle Sizer set for Pediatric and Small aortic annulus
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.