BEUDAMED
    10 results · 26ms · 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.

    AMERICA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZAVATION

    FDA UDI
    Zavation LLC·00842166152304·WHITNEY 14mmx16mm , 6deg , 08mm

    36M - Southside Electrical Coop - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588206080·36M - Southside Electrical Coop - Metal

    ENDOSCOPIC APPLICATOR

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

    HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    ENDURITY SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·December 14, 2012

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021