BEUDAMED
    15 results · 13ms · Sources: EU EUDAMED, US FDA

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    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

    FDA Recall
    Terminated ·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·Product code MUU·August 8, 2017

    5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.

    FDA Recall
    Terminated ·Mentor Texas, Inc·Product code MUU·July 27, 2007

    Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.

    FDA Recall
    Terminated ·Globalmed Logistix·Product code MUU·December 15, 2015

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    FDA Recall
    Terminated ·Shippert Medical Technologies·Product code MUU·October 20, 2017

    ASP-1020 LipoTower with Aspiration Pump. Medical use.

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code MUU·June 12, 2015

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

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code MUU·June 12, 2015

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Recall
    Terminated ·Miami Fat Supply, Inc·Product code MUU·April 21, 2016

    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code MUU·November 3, 2016

    Leksell Gamma Knife C

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·August 1, 2006

    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 9, 2008

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    Leksell Gamma Knife C

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·September 1, 2006

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corp.·February 17, 2016

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Recall
    Terminated ·Spectranetics Corp.·Product code MCW·January 15, 2016

    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MDU·December 17, 2018