BEUDAMED
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    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);

    FDA Enforcement
    Class II ·Ongoing·MicroAire Surgical Instruments, LLC·June 18, 2025

    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·June 20, 2012

    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

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·February 7, 2018

    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·September 11, 2013

    Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·September 11, 2013

    ASP-1020 LipoTower with Aspiration Pump. Medical use.

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·October 7, 2015

    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·June 8, 2016

    Endotine Transbleph 3.5 (CFD-080-0167)

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·August 3, 2016

    ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·October 7, 2015

    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·April 13, 2016

    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·April 13, 2016

    MicroAire K-Wires

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·March 15, 2017

    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).

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·June 13, 2018

    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·August 14, 2019