BEUDAMED
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    Hello,eyes® BIO Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)

    FDA 510(k)
    FDA Class 2 ·Dental

    Intai Anatomic Locking Plate and Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TDCH, 4L, 110CM, CATHETER HTR KIT

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code DYG·May 11, 2010

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2011

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 22, 2013

    ARCOS 17X150MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    ARCOS CON SZ C STD 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    REVEAL LINQ

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DSI·October 9, 2017

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014