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.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Microaire Surgical Instruments and its 1 subsidiaries with 19 510(k) clearances and 14 device recalls. The most recent is a 510(k) clearance dated Jun 20, 2025: PAL Sterilization Case.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Microaire Surgical Instruments and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 20, 2025 | PAL Sterilization CaseK243589 · KCT | 510(k) clearances |
| May 7, 2025 | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal TuClass II · Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. | Device recalls |
| Apr 25, 2025 | PAL 7020 ConsoleK244026 · QPB | 510(k) clearances |
| Dec 30, 2024 | PAL Aspiration SystemK242804 · QPB | 510(k) clearances |
| Feb 2, 2023 | SmartRelease Endoscopic Soft Tissue Release SystemK223406 · HRX | 510(k) clearances |
| Oct 14, 2022 | PAL Infiltration SystemK220318 · QPB | 510(k) clearances |
| Jun 10, 2022 | PAL SystemK212024 · QPB | 510(k) clearances |
| Jun 24, 2021 | SMARTRELEASE Endoscopic Soft Tissue Release SystemK211297 · HRX | 510(k) clearances |
| May 14, 2020 | PAL Single-Use CannulasK192694 · QPB | 510(k) clearances |
| Jun 26, 2019 | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014Class II · There was a higher than normal incidence rate of the blade not retracting when tightening. | Device recalls |
| Apr 19, 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire CClass II · The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. | Device recalls |
| May 22, 2017 | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large Class II · One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) | Device recalls |
| Feb 21, 2017 | MicroAire K-WiresClass II · Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on | Device recalls |
| May 6, 2016 | Endotine Transbleph 3.5 (CFD-080-0167)Class II · MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to m | Device recalls |
| Mar 11, 2016 | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical IndustryClass II · MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and | Device recalls |
| Feb 8, 2016 | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannulaClass II · Complaints that the cannula bent/broke during surgery. | 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
