BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

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

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704921048·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284904·WILTSE GELPI RETRACTOR 11"

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508901·

    SENSOR WALK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIOPSY HANDY, MRI BIOPSY HANDY

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·July 7, 2011

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2024

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 4, 2025

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 13, 2025

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

    14 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 20, 2025

    VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022