BEUDAMED
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    Montross Extremity Medical Hemi Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Control Devices, LLC·G2982212200·CGA 280 Regulator, 70:30 Heliox, 50 psig, Barbe...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247195·No-Profile Interbody, 39mm x 27mm x 12mm, 20 Deg

    InCompass®

    FDA UDI
    ZIMMER SPINE, INC.·00889024400481·

    J & J INSTRUMENTS

    FDA UDI
    J & J INSTRUMENTS INC·00817524025538·OPERATING SCI 6.5"" B/B STR

    Control Devices

    FDA UDI
    Control Devices, LLC·00810051631227·CGA 280 Regulator, 70:30 Heliox, 50 psig, Barbe...

    NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020039·Artificial chordal replacement prosthesis

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020138·Artificial chordal replacement prosthesis

    CADD

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·April 14, 2022

    VANGUARD CRUCIATE RETAINING TIBIAL BEARING 12MM X 63/67MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 3, 2025

    VANGUARD CRUCIATE RETAINING POROUS FEMORAL COMPONENT RIGHT 62.5MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 1, 2025

    BIOMET CRUCIATE TIBIAL TRAY 67MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 3, 2025

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD. U.K.·Product code KWB·November 5, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    PROMUS ELEMENT ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 11, 2013

    DR FOG TREATED SPONGE, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·October 19, 2020

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025