BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARROWBONE-A, ARROWBONE-B

    FDA 510(k)
    FDA Class 2 ·Dental

    ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 10, 2020

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·February 28, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 4, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·July 7, 2014

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024