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

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    ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    7400 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136021096·7400 MED W/2700 LG 2W LESS HG

    All-Purpose Arch Adapter

    FDA UDI
    Noras MRI products GmbH·04251269205675·

    All-Purpose Arch Adapter

    FDA UDI
    Noras MRI products GmbH·04251269201080·

    Iris Scissors

    FDA UDI
    Medetz Surgical Instruments LLC·G2231133970·Iris Scissor, Curved Ribbon Type, Small Blade B...

    ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PACIFIC HEMOSTASIS REFERENCE EMULSION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZIMMER AIR DERMATOME

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·August 21, 2019

    ENDURON 10D 58 OR 70ODX28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC./REG. #1818910·Product code HRY·May 15, 2013

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    ASR 300 SPIKED CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·May 20, 2011

    GMK-REVISION FEMUR REVISION PS SIZE 6 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2022

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025