Envoy Medical Corporation
Envoy Medical Corporation holds FDA 510(k) medical device clearance, cleared in 2008, with 2 FDA device recalls on record.
Top product codes for Envoy Medical Corporation
FDA recalls by Envoy Medical Corporation
- Z-2590-2018 — Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
- Z-0750-2013 — Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Envoy Medical Corporation
Data sourced from openFDA. This site is unofficial and independent of the FDA.