BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    PROFEMUR Preserve Size 1-3 Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGXO

    FDA UDI
    Oticon A/S·05707131285652·H160V2, MINIRITE 312 WL CNB AGXO

    TruLink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102271·SENSOR,SPO2,UNIVERSAL,DIXTAL

    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D-STAT RADIAL HEMOSTATIC BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·January 7, 2016

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·August 25, 2024

    COLLEAGUE PRE P1.7

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

    S8 ELITE - AMERICAS

    FDA Adverse Event
    Malfunction ·RESMED LTD.·Product code BZD·April 30, 2013

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·August 29, 2008

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 12 HOLE / L274MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·January 17, 2017

    VITAL-PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·May 24, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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