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

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    LIQUID ASSAYED MULTIQUAL PREMIUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Fertility Control

    FDA UDI
    FUJIREBIO DIAGNOSTICS, INC.·00850212007072·

    MUELLER PERFORM PLUS TAPE

    FDA UDI
    Mueller Sports Medicine, Inc.·00074676301624·1.5" PERFORM TAPE (32 ROLLS)

    ArgenZ ST 98x18 ML D3B

    FDA UDI
    ARGEN CORPORATION, THE·D818130162·Dental porcelain/ceramic restoration kit

    Accent Mini

    FDA UDI
    ORMCO CORPORATION·00889989003277·U6R ACCENT MINI DAMON 22 -18/0/12

    Drive

    FDA UDI
    Drive Devilbiss Healthcare·50822383103223·I.V.Pole,Dlx.2 Hook,5 leg,2/cs

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450200186·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197540124·Caspar Rongeur straigth 2x12mm 160mm

    Drive

    FDA UDI
    Drive Devilbiss Healthcare·00822383226064·Patient RoomIV Poles Product Description: Enfer...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197046213·Waugh Dressing Forceps cross-...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197046206·Waugh Dressing Forceps cross-...

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 2, 2002

    MULTIPLE PRIVATE LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LAWRENCE CSERION, MODEL CS-1

    FDA 510(k)
    FDA Class 2 ·Radiology

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

    BAHA FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 30, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code NVZ·June 16, 2011

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015