BEUDAMED
    14 results · 20ms · 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 ×

    GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169167407·PLATE 9240545 SPIRE Z LARGE

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464056330·EARQ F20 MINIRITE T C063

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361029267·Ø14mm X 45mm Hybrid Fusion Screw, Gen II

    Temporary Abutment

    FDA UDI
    BICON, LLC·00813110021489·4.0 x 4.5mm Temporary Abutment - 2.5mm Post

    Legend Pro DMA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OTTER SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    SELOX JT 45

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·November 10, 2014

    IDENTITY ADX XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011

    7MM FLUTED ACORN

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025