BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    ARTHREX TIBIAL GRAFTBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450658116·

    SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 6, 2019

    CREATINE KINASE (CK-NAC)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PHOSPHORUS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PELVICOL ACELLULAR COLLIGEN MATRIX

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·April 24, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    BAXTER COLLEAGUE CX

    FDA Adverse Event
    Injury ·Product code FRN·May 12, 2011

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

    NEONATAL PATIENT CIRCUIT KIT

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018