BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    POLYESTER NONABSORBABLE SURGICAL SUTURES URP

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

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001172·artVeneer life upper anteriors, BOL, B1

    CALLCORD,12FT,1/4",COOL GRAY 6C,ASCOM

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828100083·CALLCORD,12FT,1/4",COOL GRAY 6C,ASCOM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139004·

    BOTANIQ

    FDA UDI
    Inspecs U.S.A., L.C.·00841543148350·SUNGLASS

    PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 13, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 24, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 11, 2016

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

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

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