BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

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

    MODIFICATION TO VASCULAR CLOSURE DEVICE

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

    SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSULT HCG TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 18, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 12, 2011

    CONSULT HCG URINE CASSETTE 5001 25T

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 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