BEUDAMED
    20 results · 27ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008805·Zirlux 16+ B2 89x17x20

    75H - Capitol Drywall - 2-Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120942·75H - Capitol Drywall - 2-Shelf Cabinet

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120140·Screwdriver, Polyaxial, Standard, Cannulated, L...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...

    BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    A & I WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    NBCA LIQUID EMBOLIC SYSTEM 2

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code MFE·April 21, 2016

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code OVE·March 20, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 4, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 14, 2007

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024