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

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    GAMMA-BSM; BETA-BSM; EQUIVABONE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II

    Verifine

    FDA UDI
    Promisemed Medical Devices Inc.·00850062218239·The proposed device Insulin Syringe, a sterile ...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837010379·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837010898·

    Plateau-Z 10mm x 28mm x 12mm, 0°

    FDA UDI
    Life Spine, Inc.·00190837017750·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026783·PLATEAU Interbody, Curved, Bulleted, 11mm 28mm ...

    IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROPLEGE CORONARY SINUS CATHETER

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DWF·May 9, 2013

    HEARTSTART XL

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 11, 2014

    REPLACEMENT G-TUBES

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·April 12, 2011

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 11, 2016

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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 L211 PROPONENT DR SL MRI Pacemaker

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

    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

    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