BEUDAMED
    20 results · 28ms · 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 ×

    CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS

    FDA 510(k)
    FDA Class 1 ·Radiology

    Axcent Acrylics

    FDA UDI
    GARRECO, LLC·D79338450300·ORTHO LIQ PINK SC (1 QT BTL)

    Indigo™

    FDA UDI
    MEDTRONIC XOMED, INC.·20613994933687·TUBING 1845030 INDIGO 5PK

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117612·Augment Trial Size 3

    NA

    FDA UDI
    Zimmer, Inc.·00889024102323·

    NA

    FDA UDI
    Zimmer, Inc.·00889024102347·

    NA

    FDA UDI
    Zimmer, Inc.·00889024102330·

    REAGENTS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SUPPLIES FOR INSTRUMENTATION LAB FLAME

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690126522·Augment Trial Size 3

    IPC® HANDPIECE - INDIGO¿ DRILL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·October 20, 2016

    NA

    FDA UDI
    Zimmer, Inc.·00889024074521·

    NA

    FDA UDI
    Zimmer, Inc.·00889024074538·

    NA

    FDA UDI
    Zimmer, Inc.·00889024074545·

    NA

    FDA UDI
    Zimmer, Inc.·00889024074514·

    WAVEONE GOLD RECIPROCATING FILE PRIMARY 21MM

    FDA Adverse Event
    Malfunction ·TULSA DENTAL PRODUCTS LLC·Product code EKS·January 6, 2020

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 3, 2014

    NOVA MAX PLUS GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORP.·Product code NBW·November 8, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR COPROATION·Product code MVK·September 10, 2010

    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