Microaire Surgical Instruments, LLC
Microaire Surgical Instruments, LLC holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2025, with 14 FDA device recalls on record.
Top product codes for Microaire Surgical Instruments, LLC
FDA recalls by Microaire Surgical Instruments, LLC
10 most recent of 14- Z-1975-2025 — Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
- Z-2222-2019 — SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
- Z-2107-2018 — MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
- Z-0412-2018 — SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
- Z-1407-2017 — MicroAire K-Wires
- Z-2294-2016 — Endotine Transbleph 3.5 (CFD-080-0167)
- Z-1834-2016 — Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
- Z-1328-2016 — MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
- Z-1323-2016 — MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
- Z-2821-2015 — ASP-1020 LipoTower with Aspiration Pump. Medical use.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Microaire Surgical Instruments, LLC
- K243589 — PAL Sterilization Case
- K244026 — PAL 7020 Console
- K242804 — PAL Aspiration System
- K220318 — PAL Infiltration System
- K212024 — PAL System
- K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K171286 — PAL Multi-Use Cannulas and PAL Manual Wand
- K150779 — LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
- K113128 — MICROAIRE SURGICAL INSTRUMENTS LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.