BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PremEco Line set-up wax, 95g

    FDA UDI
    Merz Dental GmbH·D7091030076·PremEco Line set-up wax, 95g

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037306161·RATCHET HANDLE

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0300060·Egg Handle, 1.75" Fixed Qtr Sq Cann Imp Crimson

    MITEK CUFFTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELL-CHEX

    FDA 510(k)
    FDA Class 2 ·Hematology

    4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·April 2, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011

    8030916-2008-00009

    FDA Adverse Event
    Other ·Product code FSA·April 3, 2008

    MAKOPLASTY® PARTIAL KNEE END EFFECTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 8, 2017

    MAKOPLASTY® PARTIAL KNEE END EFFECTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 5, 2016

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013