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

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    OXYBOX SYSTEM

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

    ER150/M2

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

    EASI 12 LEAD ALGORITHM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERFORMANCE TOTAL KNEE PROSTHESIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019

    PERFORMANCE DISTAL FAB LM/RL MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    PERFORMANCE DISTAL FAB LL/RM MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    VANGRD CR POR/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    VANGUARD CR POROUS/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 23, 2016

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 27, 2013

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Malfunction ·MPROC, VILLALBA·Product code MHY·March 8, 2011

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·April 2, 2008

    VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 20, 2017

    VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·May 12, 2017

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018