BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044131·Spreader SE #3

    Essential Kit

    FDA UDI
    MEDIVATORS INC.·40677964008526·Essential Kit includes Suction Tubing, Pentax V...

    Synergy Disc Instruments

    FDA UDI
    Synergy Spine Solutions Inc·M67091000009360·Trial, Medium, 6mm, 0°

    ENTEC REFLEX WAND 55, MODEL E4055-00

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

    SYNERGY VLS CAP NUT MODELS 2206, 6102

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    FLOW-I C20 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·June 19, 2025

    REMOTE ALARM

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·February 27, 2013

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    COLIBRI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·August 12, 2014

    Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936

    FDA Recall
    Terminated ·I-Flow Corporation·Product code FRN·March 5, 2003

    FLOW-I C20 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·June 19, 2025

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    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

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. 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

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

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