ClearanceBrief
Company ยท US

International Life Sciences

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (1 in 12 months)
3recalls (3 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon4
FTLMesh, Surgical, Polymeric1
MBIFastener, Fixation, Nondegradable, Soft Tissue1
QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 9, 2026K260317Artelon Convenience Kits
International Life Sciences
QWJ
May 26, 2023K230316FlexBand; FlexPatch; FlexBand Plus
International Life Sciences
OWW
Sep 2, 2020K200503ATL Anchors
International Life Sciences
MBI
Sep 27, 2019K192112FlexBand Plus
International Life Sciences
FTL

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 11, 2026International Life Sciences
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Open, Classified		 OWWK200503
K230316
Mar 11, 2026International Life Sciences
Artelon FlexBand Plus Ref: 41054 & 41057
Open, Classified		 OWWK230316
Mar 11, 2026International Life Sciences
Artelon FlexBand Dynamic Matrix Ref: 31057
Open, Classified		 OWWK200503
K230316
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