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

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    HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDLINE INDUSTRIES, INC.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10198459467486·AMNIOCENTESIS KIT

    Oticon

    FDA UDI
    Oticon A/S·05707131165305·K140, ITC/ITE AP WL R BE

    MicroScan

    FDA UDI
    Beckman Coulter, Inc.·15099590656010·MicroScan Inoculum Water with PLURONIC, 15 mL

    ZAVATION TAP

    FDA UDI
    Zavation LLC·00197157013264·TIGER 2 TAP, Ø 7.0mm, EXCELSIUSGPS CANNULATED

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·June 11, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011

    HEARTSTART FR3 TEXT, BASIC BUNDLE, UKENG

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 3, 2013

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 25, 2014

    20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 17, 2017

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·September 23, 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

    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

    Hemodialysis Delivery System, Software Version 2.x.

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

    ACCOLADE DR SL (Model L301)

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