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

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    SMG Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304448773·

    SUPER CHAIR FOR KIDS BY ORION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    THEKEN ATOLL CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 28, 2011

    RGX 3 PEG SER A PATELLA 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 25, 2018

    BIOMET POLISHED FINNED TIB TRAY 83MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 4, 2025

    VNGD CR TIB BRG 18X79/83

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·February 5, 2024

    VANGUARD LIPPED TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 24, 2017

    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

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, 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 Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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