BEUDAMED
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    OptiMesh Multiplanar Expandable Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEAVE ACTIVE PFC CVD 10MM SZ5

    FDA Adverse Event
    Injury ·K830927·Product code JWH·April 18, 2012

    GS CORPATCH

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code MKJ·May 28, 2024

    DURABLUE STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDERED VINYL EXAM GLOVES, WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code MUZ·September 1, 2011

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·November 17, 2008

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 17, 2013

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 18, 2025

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020