BEUDAMED
    15 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 ×

    EndoTool IV 1.10

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III

    Intraoral Scan Body STD

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075236·

    DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2024

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 13, 2023

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

    CORTICAL BONE SCR 50MM

    FDA Adverse Event
    DEPUY ACE S.A. 'R.L.·Product code HSB·September 11, 2008

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 1, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    XIA BLOCKER

    FDA Adverse Event
    Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·March 19, 2013

    UNK - CAGE/SPACERS: SYNCAGE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVD·September 19, 2019

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014