Sdi Limited

Medical device manufacturer in Bayswater, Aust.

9510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K222583Stela Capsule SystemEBF · Traditional 10/28/2022SE
K222581Stela Automix SystemEBF · Traditional 10/28/2022SE
K214118Riva Cem AutomixEMA · Traditional 08/30/2022SE
K191656ZipbondKLE · Traditional 12/02/2019SE
K172047Riva StarPHR · Traditional 04/11/2018SE
K102984AuraEBF · Traditional 12/08/2010SE
K081273Ultracaps SOIV · Traditional 07/10/2008SE
K073043Set PPEMA · Traditional 12/14/2007SE
K833176Sdi Surgical DrapeKKX · Traditional 04/04/1984SE

Recalls

RecallProductInitiated
Z-2954-2026 Class IIDentsply Sirona Capsule Mixer Model No. 5546068Potential for electrical discharge from unit when unplugged. 07/20/2026Open, Classified