BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    CR 85-X

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 16, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·April 28, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 4, 2021

    SPHYGMOCOR MX MODEL SCOR-MX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEETHMATE F-1

    FDA 510(k)
    FDA Class 2 ·Dental

    DRIVESHAFT FOR SCREWDRIVER 90°

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·November 6, 2014

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 17, 2013

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION GLENOSPHERE DISTRACTOR

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSD·June 17, 2008

    UNKNOWN PRODUCT HOWMEDICA TOTAL LEFT KNEE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 13, 2011

    SHAFT FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code DZI·September 10, 2015

    HANDLE FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 4, 2018

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015