BEUDAMED
    17 results · 22ms · 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 ×

    PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010761·Zirlux 16+ A2 100X22

    TEWA

    FDA UDI
    asia-med GmbH·04251282510183·TeWa CJ-Type 3075: coated acupuncture needles ...

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502867·TeWa CJ-Type 3075: coated acupuncture needles ...

    YPSOPUMP INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

    YPSOPUMP INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 16, 2025

    LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JAX GRANULES BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRACISION * SURG DEV, CURVED SHEARS, ENDO

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·March 8, 2013

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    IMUFLEX DISPOSABLES

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code CAK·March 19, 2013

    KINETIX PTCA GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 9, 2011

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024