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

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    Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131285874·H15V2, RITE 312 WL CNB

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120540·Guidewire 1.6x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120557·Guidewire 1.6x150mm Sgl Trocar

    Tibial Keel Slider

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215041755·

    BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 16, 2022

    ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 11, 2022

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    WALLSTENT ENTERAL DUODENAL STENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·September 3, 2008

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

    FDA Enforcement
    Class II ·Ongoing·Remel Europe Ltd.·April 29, 2026

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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