BEUDAMED
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    REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450295779·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423714·

    SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ST. JOSEPH HSP BALTIMORE MD1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 20, 2013

    SROM STM ST, 36+6L NK, 11X16X150

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·February 24, 2011

    CRANIAL ACCESS KIT

    FDA Adverse Event
    CODMAN & SHURTLEFF, INC/MEDOS S.A.·Product code GWM·March 7, 2008

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    SMART, PERFUSION PACKS, CONNECTORS, TUBING

    FDA Adverse Event
    Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

    CSC14 CARDIOLOGIA HEAT EXCHANGER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q 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.·October 18, 2017