BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    QACA IGG/IGM ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120202411·Carbide - Excavating and fissure burs

    Illusion™ Univeral Restorative

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310202413·Safco universal restorative A1 syr

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717102397·Midway Select Bite Reg Regular Unflavrd

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036019594·

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

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

    QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Injury ·MATORHTO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    Widex

    FDA UDI
    Widex A/S·05706069828139·WIDEX EVOKE EBB3D DEMO (Silver Grey ) 440, Tele...

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·September 12, 2025

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 16, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 19, 2014

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 26, 2008

    AIA-2000

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·October 4, 2019

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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