BEUDAMED
    1,061 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.

    FDA Recall
    Terminated ·Sony Medical Systems·Product code FWB·January 13, 2015

    Natus neoBLUE blanket LED Phototherapy system which includes the following items: 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 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·March 16, 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 Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·October 28, 2016

    Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HPP·June 11, 2014

    Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. Affected Part Numbers and Description: 006244 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 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·September 16, 2016

    The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·October 1, 2009

    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1

    FDA Recall
    Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LNH·August 20, 2018

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD Patient Size: 50-70kg

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD Patient Size: 30-50kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD Patient Size: 30-50kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FSY·November 7, 2011

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD Patient Size: 30-50kg " Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD Patient Size: 50-70kg " Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code OHS·June 18, 2008

    Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FSY·August 23, 2011