BEUDAMED
    113 results · 27ms · 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 Regulation: Us FDA ×

    FITPACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

    Durable BP Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935104117·

    MONOFILAMENT BIOSYN SUTURE

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

    DAUM DOUBLE-SHOOT BISOPSY GUN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 1, 2021

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 19, 2013

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·February 24, 2017

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code NIO·July 25, 2017

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·June 11, 2008

    CONFIENT

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 15, 2011

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen LPS-Flex/LPS Mobile Bearing Knee System