BEUDAMED
    23 results · 31ms · Sources: EU EUDAMED, US FDA

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    SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SleepWeaver 3D Large Headgear only

    FDA UDI
    CIRCADIANCE, LLC·B036101517·SleepWeaver 3D Large Headgear only

    MicroScan

    FDA UDI
    Beckman Coulter, Inc.·15099590655709·MicroScan Rapid Indole Reagent-F

    BETA TITANIUM ARCHWIRE

    FDA UDI
    Ortho Organizers, Inc.·00190707067496·.018 X .018 Lower Beta Titanium Oval Arch Form ...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501422·Gutta Percha Points is used to root canal filin...

    LUTE; CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    DELTAFILL18 8MM X 35CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·May 20, 2011

    LEADCARE II BLOOD LEAD TESTING SYSTEM

    FDA Adverse Event
    Malfunction ·MAGELLAN DIAGNOSTICS, INC.·Product code DOF·January 12, 2026

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    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

    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