BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    THE SAMUELS RETROGRAD VALVULOTOME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Obtura Spartan

    FDA UDI
    OBTURA SPARTAN ENDODONTICS·00816168020404·EMS Threaded Tip Set CPR 1-5E Contains: 932-001...

    MODEL #27224P CONTINUOUS FLOW PUMP

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

    CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014

    PHOENIX GUIDEWIRE

    FDA Adverse Event
    Injury ·LAKE REGION MEDICAL LIMITED·Product code DQX·May 22, 2026

    KARL STORZ

    FDA Adverse Event
    Injury ·KARL STORZ ENDOSCOPY·Product code KQT·January 21, 2004

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 17, 2010

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·July 14, 2014

    PHOENIX GUIDEWIRE

    FDA Adverse Event
    Malfunction ·LAKE REGION MEDICAL LIMITED·Product code DQX·May 12, 2026

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021