BEUDAMED
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    THE BELMONT RAPID INFUSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304002876·

    FD TENS 2070

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPROVIS IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BMT SPLINED KNEE STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 2, 2014

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929038925·Corpectomy, 14Dx16Wx54H 6°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929065341·Corpectomy, 14Dx16Wx54H 0°

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    NC QUANTUM APEX PTCA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 27, 2011

    PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BIOMET OFFSET TIBIAL TRAY 63MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBV·January 25, 2017

    ONCOLOGY SALVAGE SYSTEM - NON-MOD PROX TIB 5CM 9X150

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017

    BIOMET OFFSET TIBIAL TRAY ADAPTOR 5.0 MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBV·January 25, 2017

    FINN KNEE PROSTHESIS - FEMORAL BUSHING SET OF 2

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    BIOMET SERIES A THIN PATELLA 37MM X 8.6 MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 25, 2017

    ONCOLOGY SALVAGE SYSTEM - REINFORCED YOKE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017

    FINN KNEE PROSTHESIS - LOCK PIN

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    BIOMET SPLINED KNEE STEM 10MM X 80MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 25, 2017

    VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60 MM RL/LM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 25, 2017