BEUDAMED
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    SmartChest

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Medos International Sàrl·10886705011223·ACORN REAMER, STERILE 20 - 130mm (Plus or Minus...

    TP Original Wire

    FDA UDI
    TP ORTHODONTICS INC·00192029028889·Standard Plus Round

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102893·JAFFE-BECHERT ROTATOR 9MM

    SNORENTI

    FDA 510(k)
    FDA Class 2 ·Dental

    DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 28, 2026

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·April 28, 2026

    MESH COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 26, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 17, 2014

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 18, 2013

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

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

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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