BEUDAMED
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    CATHETER CARE TRAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556602287·SOD AWL 3.5MM

    BEL-CAT

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E1 RINGLOC BIPOLAR 28X51MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019

    BIOMEX SHELL PC DIA48MM LN 22

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 2, 2015

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014

    INTEGRATED APD SET W/CASSETTE3 PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010

    PELVICOL ACELLULAR COLLIGEN MATRIX

    FDA Adverse Event
    Injury ·COVIDIENT, FORMERLY TISSUE SCIENCE·Product code FTL·August 24, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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