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

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    BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180148451·Stiletto Osteotome 8 1/2" Straight 3/8" [10mm]

    DISCOVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Optiflux Series of Dialyzers F160NR, F180NR, F200NR

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

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 18, 2012

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·May 24, 2024

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·May 24, 2024

    FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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