BEUDAMED
    14 results · 25ms · 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 ×

    Arthrex Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111225468·MOYNIHAN ARTERY FCP CVD 5 3/4"

    POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 5, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    6000 CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 23, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 22, 2011

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 17, 2018

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021