BEUDAMED
    19 results · 24ms · 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 ×

    OC-FLEX Flexible IntraOral Cannula

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LoFric® Sense™

    FDA UDI
    Wellspect AB·07333387022604·Single Use Urinary Catheter LoFric Sense Nelato...

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517292339·CoRoent® XLFW, 12x22x50mm

    LoFric® Sense™

    FDA UDI
    Wellspect AB·07392532086366·Single Use Urinary Catheter LoFric Sense Nelato...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036221·Assembly, Block, 2.0/2.4mm Cannulated Headless

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122261·Kwire .062x6" (1.6x150mm) Threaded

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122278·KWire .062x6" (1.6x150mm)

    GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES

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

    MULTICATH EXPERT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 14, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 10, 2023

    STERIS

    FDA Adverse Event
    Malfunction ·VILEX·Product code HTY·April 6, 2005

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 13, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

    PUMP 1886 780G OUS BLE PUMP MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 21, 2024

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    FDA Enforcement
    Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019

    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018