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

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    BIMECO FILTERED EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUPRO® Extra Care™ Prophy Paste with fluoride & NovaMin®

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038016051·NUPRO® Extra Care Prophy Paste, Citrus Mint, St...

    Span-America

    FDA UDI
    SPAN-AMERICA MEDICAL SYSTEMS, INC.·H933801605·GEL-T 16X16 PU ULTRA/BVINYL

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118047·Jeweler Forceps, #3, Straight

    ACUMED

    FDA UDI
    Acumed LLC·10806378050275·Standard Stem Reamer 5mm

    SURE-SNAP

    FDA UDI
    Gc Orthodontics America Inc.·E53580160500001·SURE-SNAP 1. MOLAR UPR RGT SZ 05

    MYLABONE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS C 513 ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 24, 2025

    COBAS C 513 ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 10, 2025

    ELECSYS T3

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·November 5, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 18, 2012

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 16, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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

    ACCOLADE SR SL MRI (Model L310)

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