International Life Sciences

Medical device manufacturer in Sandy Springs, GA.

4510(k) clearances
0PMA approvals
3recalls

Device types

510(k) clearances

510(k)DeviceDecision
K260317Artelon Convenience KitsQWJ · Traditional 04/09/2026SE
K230316FlexBand; FlexPatch; FlexBand PlusOWW · Traditional 05/26/2023SE
K200503ATL AnchorsMBI · Traditional 09/02/2020SE
K192112FlexBand PlusFTL · Special 09/27/2019SE

Recalls

RecallProductInitiated
Z-1556-2026 Class IIArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor…Augmentation devices failed bacterial endotoxin testing. 02/06/2026Open, Classified
Z-1555-2026 Class IIArtelon FlexBand Plus Ref: 41054 & 41057Augmentation devices failed bacterial endotoxin testing. 02/06/2026Open, Classified
Z-1554-2026 Class IIArtelon FlexBand Dynamic Matrix Ref: 31057Augmentation devices failed bacterial endotoxin testing. 02/06/2026Open, Classified