BEUDAMED
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    THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040128067·STAINLESS STEEL WIRE 14 RECTANGULAR .021 x .025

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496063254·SOCKS FOR YOU BAMBOO POIS, SIZE L, BLU NAVY, GR...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111203398·BERLINER PERC HAMMER 6.75"

    CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CERTAIN¿ TITANIUM HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·September 28, 2023

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DENTSPLY PROFESSIONAL·Product code EKX·February 26, 2013

    OPTISTAR LE MULTIPAK (2-60ML SYRINGES

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·March 22, 2011

    PFC SIGMA C/S NPOR FEM RT SZ 4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 18, 2008

    ZIMMER M/L TAPER FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LZO·February 17, 2016

    KINECTIV MODULAR NECK

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·May 26, 2016

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    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

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025