BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NELATON-, FEMALE - OR TIEMANN CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PEDIATRIC SOFTVENT

    FDA Adverse Event
    Injury ·UNOMEDICAL SDN BHD·Product code BTR·February 12, 2018

    IFA SENSIBAC TOBRAMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SUTURE REMOVAL KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MINI STEP 7/8MM CANN/DILATOR WITH SLEEVE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·May 20, 2014

    VICTORY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010

    WIRELESS BATTERY MODULE G

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·November 21, 2012

    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·September 21, 2016

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013