BEUDAMED
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    SAPPHIRE DETACHABLE COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832073924·Hudson Connector

    NIDEK CO., LTD.

    FDA registration
    NIDEK CO., LTD.·25 products·🇯🇵 Japan

    RESPONSE 2000 HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 2, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 28, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·April 16, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

    LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016