BEUDAMED
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    THERMAL CAUTERY FORCEPS

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

    Preat

    FDA UDI
    Preat Corporation·00842092169728·Straumann® TL RN-compatible Engaging Ti Base X ...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126021·

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092122709·Straumann Tissue Level RN x 6mm Titanium Base

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001262·artVeneer life lower anteriors, UIM, B3

    GOLDFINGER DEVICE

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

    BOHN FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AIRLIFE PEDIATRIC OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, MEDIUM CONCENTRATION

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL INC.·Product code CAT·May 12, 2023

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·February 25, 2011

    GE OEC 2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·February 22, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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

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