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 ×

    IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140

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

    SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 16, 2019

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 3, 2013

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 2, 2011

    LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 19, 2022

    SUPERA

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code NIP·October 16, 2024

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020