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

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    SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I

    VASCUPUNCTURE ACCESS WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TOTAL ASR FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·May 9, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·September 19, 2014

    CAPIO NON-ABSORBABLE SURGICAL SUTURES

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GCJ·May 3, 2011

    RICKHAM RESERVOIR

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015

    CROSSTIE

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code HWC·September 29, 2022

    VENT RES TR RICKHAM LG BA

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    Model Number L101, ESSENTIO DR SL Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021