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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SMART COUPLER, MODEL M015401

    FDA 510(k)
    FDA Class 2 ·Neurology

    SHARGHP A.V. FISTULA NEEDLE SET

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

    VERSALINK TITANIUM ROD-TO-ROD COUPLERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 8, 2025

    PROFILE BIABUT 4.0 -Ø5.5

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026

    PINNACLE SECTOR II CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 23, 2013

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 1, 2011

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

    PROFILE 3D

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

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