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Arrow International, Inc., Division of Teleflex Medical Inc.

14 FDA 510(k) clearances · Recalling firm

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◉ Watch Arrow International, Inc., Division of Teleflex Medical Inc.

RecordFirmDate
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counte recall (Z-1055-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aorti recall (Z-1056-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow IAB is utilized fo recall (Z-1057-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aorti recall (Z-1058-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra a recall (Z-1059-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra a recall (Z-1060-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aorti recall (Z-1061-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra a recall (Z-1062-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra ao recall (Z-1063-2016)Arrow International, Inc., Division of Teleflex Medical Inc.2016-03-11
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U recall (Z-0790-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U recall (Z-0791-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS recall (Z-0792-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS recall (Z-0793-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Cathete recall (Z-0969-2011)Arrow International, Inc., Division of Teleflex Medical Inc.2010-12-23

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Every clearance here is in the API, with alerts when new ones post.