BEUDAMED
    16 results · 26ms · 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 ×

    PICO Single Use Negative Pressure Wound Therapy System

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

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000813·MCK Onlay Tibia Baseplate

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107170·TRIAL 90-SRK-180618 POLY PS 6X18MM

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

    FDA 510(k)
    FDA Class 2 ·Hematology

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    XLBLEU

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·May 15, 2019

    MCK TIBIAL ONLAY INSERT-SZ 8-8MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·March 7, 2017

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    HUDSON AIR CUSHION MASK,NEONATE

    FDA Adverse Event
    Malfunction ·Product code BSJ·September 27, 2021

    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 Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    HUDSON AIR CUSHION MASK,NEONATE

    FDA Adverse Event
    Malfunction ·Product code BSJ·September 27, 2021

    HUDSON AIR CUSHION MASK,NEONATE

    FDA Adverse Event
    Malfunction ·Product code BSJ·September 27, 2021

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016