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Hydrogel Spacer

FDA product code OVB · Class 2 · Radiology

6
Registered devices
2,087
Adverse events
2
Recalls
7
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-02-24Boston Scientific CorporationUsers need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warni
2022-02-24Boston Scientific CorporationUsers need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warni

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.