BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    DxFLEX Flow Cytometer; ClearLLab 10C Panels

    FDA 510(k)
    FDA Class 2 ·Hematology

    K-Systems

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120017·Assisted Reproduction Accessories

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111364778·SKLARLITE ADSON DRESS SER 4.75

    Leitz Anastomosis Clamp 20cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034063521·Leitz Anastomosis Clamp 20cm

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103258·JAFFE LENS SPATULA 0.5MM

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702403237·Elvarex 2/Thigh High/Closed Toe, Knee Comfort/T...

    FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING

    FDA 510(k)
    FDA Class 2 ·Dental

    VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    3.2MMX20MM RNGLC+ ACET DRL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 1, 2021

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 11, 2014

    NOT DEVICE SPECIFIC/NO DEVICE MALFUNCTION

    FDA Adverse Event
    Injury ·Product code KAM·August 25, 2011

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 18, 2013

    3.2MMX15MM RNGLC+ ACET DRL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 1, 2021

    3.2MMX30MM RNGLC+ ACET DRL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 1, 2021

    3.2MMX30MM RNGLC+ ACET DRL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 1, 2021

    3.2MMX15MM RNGLC+ ACET DRL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·October 1, 2021

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ACCOLADE DR SL MRI (Model L311)

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