BEUDAMED
    29 results · 34ms · 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 ×

    LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496040927·CATHERINE CCL.1, SIZE L, NERO, GRADUATED COMPRE...

    MODIFICATION TO PROLITE PULSED LIGHT SYSTEM

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

    ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4

    FDA 510(k)
    FDA Unclassified ·Unknown

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 11, 2012

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 1, 2022

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·December 29, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 8, 2013

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 23, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·May 9, 2008

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 24, 2015

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013

    ADAPTER SLEEVES 12/14 +8

    FDA Adverse Event
    Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·November 4, 2015

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 1, 2022

    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    ADAPTER SLEEVES

    FDA Adverse Event
    Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·February 2, 2016

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·February 2, 2016

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 23, 2015