BEUDAMED
    24 results · 27ms · Sources: EU EUDAMED, US FDA

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    Algidex Ag Silver Alginate Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    MYSPINE MC VERTEBRA L04

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018

    REVERE SACRAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REDUCTION CANNULATED PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023

    MYSPINE S01 DRILL BASED GUIDE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018

    MYSPINE-MC DRILL GUIDE L03

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023

    MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2013

    ETS FLEX ARTICNG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2011

    PRIME CARE (R) TRANSCEND BASIC MATTRESS

    FDA Adverse Event
    Malfunction ·PRIMUS MEDICAL, LLC·Product code IKY·October 10, 2014

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·January 17, 2024

    ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024

    MYSPINE MYSPINE MC DRILL BASED GUIDE L04

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020

    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