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    ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705094·Judd-Allis Tissue Forceps 6" (15cm), 3x4 teeth,...

    SYLE SMARTIP

    FDA 510(k)
    FDA Class 1 ·Dental

    MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·October 3, 2014

    36MM COCR MODULAR HEAD +6MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 31, 2013

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 31, 2011

    BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

    BD MAXZERO¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    AAMI LEVEL 3 SURG HOOD

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FYA·June 9, 2016

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013