BEUDAMED
    9 results · 27ms · 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 ×

    ACROMED DOUBLE SUBLAMINAR WIRE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867133556·GD CALC FRAC PERCPLT,AP/PT,STD,RT

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ARGENCO 40 TYPE III DENTAL GOLD ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM INC.·Product code MDS·June 25, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 3, 2013

    REPLY

    FDA Adverse Event
    Injury ·SORIN BIOMEDICA CRM S.R.L.·Product code NVZ·November 4, 2010

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025