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

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    EYE-CEPT STERILE SALINE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707097419·BKT 21 INTERACTIVE SL 22 T+17 A+4

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642117912·Modular Spacer, 34 mm (W) x 28 mm (L) x 19 mm (...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110221911·MYSTIQUE® MB Roncone 018/UL2 10T 8A HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110221001·MYSTIQUE® MB Base Rx 018/UL2 8T 9A

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110221901·MYSTIQUE® MB Roncone 018/UL2 10T 8A

    JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIWAVE3

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 28, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·September 10, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2011

    TALENT AAA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·March 12, 2014

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 12, 2014

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024