Medical Device Manufacturer · US , Durham , NC

Riemser Arzneimittel AG - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2012

Recent clearances: REVOIS PRO IMPLANT STSYEM, REVOIS IMPLANT SYSTEM, CERASORB PLUS

3
Total
3
Cleared
0
Denied

Riemser Arzneimittel AG, is a pharmaceutical and medical device manufacturer with a manufacturing facility in Durham, US. The company develops and produces medical devices across multiple therapeutic areas.

Riemser received 3 FDA 510(k) clearances from 3 total submissions between 2012 and 2013. The company's regulatory focus centered on Dental devices, which represented the entirety of its FDA submissions. Notable cleared products include implant systems and bone regeneration materials. The company has not received additional FDA 510(k) clearances in over a decade and should be treated as a historical regulatory record.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

FDA 510(k) Regulatory Record - Riemser Arzneimittel AG

3 devices
1-3 of 3
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