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

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    FULL CARE Disposable PVC Nelaton Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047012·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 45mm,...

    MaxFuse,VBR, 12 (D) x 14 (W) x 28 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468056193·VBR, 12 (D) x 14 (W) x 28 (H)

    ECHOSYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PASSEO-18 5/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 6/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 2.5/170/130

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 6, 2011

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code OJX·June 7, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    DELTA CER HEAD 12/14 36MM +8.5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LZO·June 23, 2023

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023