BEUDAMED
    21 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 ×

    TIGER SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878059929·GM ZYGOMA-S SURGICAL CASE

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176163172·Bone cutter FG XL 1,2 mm, pu: 1 St.

    ADVIA Centaur® VB12 Diluent

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414175300·VitaminB 12 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776371883·Mueller-Style Phlebectomy Hook

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306815973·Volkman Retractor, 4 Prong, Blunt, Length: 21.5...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306815980·Volkman Retractor, 4 Prong, Sharp, Length: 21.5...

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 7, 2011

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·August 13, 2012

    MODULAR FOOT SYSTEM - 2.7 MM MODULE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 1, 2011

    ADULT DUAL HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 31, 2011

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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