Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Smith & NephewLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ArthroCare with 149 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Mar 30, 2026: FLOW FLEXTEND Wand (72290039).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 30, 2026 | FLOW FLEXTEND Wand (72290039)K254122 · GEI | 510(k) clearances |
| Mar 25, 2026 | LYNX COBLATION Laryngeal Wand (72290254)K253680 · GEI | 510(k) clearances |
| May 8, 2024 | FLOW 90? WandK240964 · GEI | 510(k) clearances |
| Dec 11, 2023 | INTELLIO SHIFT SystemK232290 · GEI | 510(k) clearances |
| Jun 26, 2023 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)K230914 · GEI | 510(k) clearances |
| Sep 1, 2022 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION SystemK220563 · GEI | 510(k) clearances |
| Jun 24, 2021 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandK210423 · GEI | 510(k) clearances |
| Dec 18, 2020 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation SystemK202006 · GEI | 510(k) clearances |
| Aug 17, 2020 | Speed Stitch Needle CassetteClass II · Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be ma | Device recalls |
| Feb 21, 2019 | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971Class II · The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and th | Device recalls |
| Mar 3, 2016 | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF Class II · During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at | Device recalls |
| Oct 26, 2015 | Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal proceClass II · There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray | Device recalls |
| Jun 2, 2015 | EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablatiClass II · Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
