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

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    LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331134593·grooved director & tongue tie, stainless steel,...

    HUMPHREY OCT3

    FDA 510(k)
    FDA Class 2 ·Radiology

    YOUNG-HEALTH SUPER EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYRINGE 5ML LS SP125

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 9, 2021

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

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

    4FR PICC BASIC TRAY

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS INC.·Product code DQY·August 28, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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

    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