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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Wisp

    FDA UDI
    Respironics, Inc.·00606959040052·Wisp Mask, Fabric Frame, with Headgear, Petite,...

    MINI SHOPPER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARCHITECT HE4 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code OIU·February 6, 2026

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 6, 2013

    6.5CM ADULT CRANI ATTACHMT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 16, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 18, 2011

    NUTRILINE

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·May 6, 2021

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·July 3, 2019

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015