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Smith and Nephew, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories6
Latest FDA decision2026-06-04
TypeNumberDevice NameCodeDateActions
PMA P210034 Implant, resorbable, for articular osteochondral repairQRU2026-06-04 View
510(k) K222501 Regeneten Bioinductive ImplantOWY2023-05-11 View
510(k) K221740 SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)GCJ2022-10-20 View
510(k) K191177 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera HeadGCJ2019-08-23 View
510(k) K183232 Double ENDOBUTTON Fixation DeviceHTN2019-03-12 View
510(k) K181746 MICRORAPTOR Knotless Suture AnchorMAI2018-09-28 View
510(k) K180361 MICRORAPTOR REGENESORB Suture AnchorMAI2018-05-30 View
510(k) K163034 SUTUREFIX Curved Suture AnchorMBI2016-12-07 View