BEUDAMED
    10 results · 20ms · 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 ×

    SeaSpine Reef TH System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    DRILL BIT Ø17 CANN F/PFNA

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·June 27, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022