BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIFEPAK 20E

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER

    FDA Adverse Event
    Injury ·ORIGEN·Product code DWF·June 9, 2015

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 10, 2014

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code MCX·July 23, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 30, 2013

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·January 18, 2019

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2019

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·August 25, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·February 3, 2021

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·January 8, 2025

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·February 10, 2022

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 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 Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

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