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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    IB CLINIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636621·CoRoent Ant TLIF PEEK, 12x13x30mm 12°

    ArgenPMMA 95x25-A2

    FDA UDI
    ARGEN CORPORATION, THE·D818123302·Crown And Bridge, Temporary, Resin

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619043735·TD Catheter, 8F, 5 lumen, 110 cm, RA/RA, Hepari...

    TD TORQUE-LINE CATHETER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DYG·September 3, 2013

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180515419·Osteotome, 3/8", Straight

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180515433·Osteotome, 3/8", Curved

    STEMPRO MSC SFM

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

    ECHELON POROUS PLUS HA HIP STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·May 21, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·September 26, 2014

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·June 14, 2011

    THREE PEG PATELLA 41MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 26, 2025

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 1, 2024

    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 Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    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