BEUDAMED
    15 results · 61ms · 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.

    NAKED CUSHION SEAT

    FDA Adverse Event
    Injury ·INVACARE TAYLOR STREET·Product code KIC·April 12, 2019

    JAY FLOLITE PAD

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL (US) LLC·Product code KNN·August 14, 2021

    JAY FLUID PAD

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC·Product code KNN·August 13, 2021

    GEL-FOAM PAD

    FDA Adverse Event
    Death ·SKIL-CARE·Product code KNN·October 21, 2000

    JAY FLUID PAD

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL (US) LLC·Product code KNN·August 13, 2021

    GEL FILLED CUSHION

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Gel Ovations Europe Limited·145 devices

    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·October 3, 2012

    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·October 3, 2012

    The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD system. The Left and Right Pads are mirror images.

    FDA Recall
    Terminated ·Integra Limited·Product code FWZ·July 27, 2012

    The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD system. The Left and Right Pads are mirror images.

    FDA Recall
    Terminated ·Integra Limited·Product code FWZ·July 27, 2012

    G7 LONGEVITY NEUTRAL 36MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 1, 2024

    G7 PPS LTD ACET SHELL 54F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 1, 2024

    ECHO POR FMRL LAT NC 13X145MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 1, 2024

    BONE SCR 6.5X35 SELF-TAP

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·May 1, 2024

    BIOLOX DELTA MODULAR CERAMIC FEM HD 36/0MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 19, 2024