BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    Senhance Surgical System

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM

    Tissue Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

    ELECTRO INTERSTITIAL SCAN

    FDA 510(k)
    FDA Class 2 ·Neurology

    Mirus Ligating Clip, Mirus Ligating Clip Applier

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

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 9, 2018

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code OZO·October 13, 2014

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    FDA Adverse Event
    Malfunction ·MATERIALISE N.V.·Product code JWH·June 28, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025