BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Monoject

    FDA UDI
    Cardinal Health 200, LLC·10192253025071·Hypodermic Safety Needle 25G x 1.5 in. (0.5 x 3...

    Monoject

    FDA UDI
    Cardinal Health, Inc.·10884521544697·Hypodermic Safety Needle

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DM1825150·Medium 15-Degree 3DP LLIF - 18mm x 25mm

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIM1825150·Medium 15 DEG Titanium LLIF

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIL1825150·Large 15 DEG Titanium LLIF

    ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

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

    NP15

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

    COMPR NANO HMRL PPS 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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