BEUDAMED
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    GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

    FDA 510(k)
    FDA Unclassified ·Unknown

    PULL THRU CASSETTE REFILL PACK (180X12)

    FDA UDI
    MEDIVATORS INC.·40677964021495·PULL THRU CASSETTE REFILL PACK (180X12)

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470025961·GRADIA® DIRECT X Unitip 10 tips (3g/16mL) -X-AO2

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161292191·GRADIA® DIRECT X Unitip 10 tips (3g/16mL) -X-AO2

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 19, 2021

    LIFERX

    FDA 510(k)
    FDA Class 2 ·Radiology

    ETEST GATIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    PORTEX GENERAL ANESTHESIA CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code OYC·March 13, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·February 8, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024