BEUDAMED
    33 results · 22ms · Sources: EU EUDAMED, US FDA

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    STERRAD SEALSURE CHEMICAL INDICATOR TAPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV

    DELRIN PATELLA HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896093843·DELRIN PATELLA HANDLE

    PMT Drill Cutter

    FDA UDI
    adeor Medical AG·04251388958339·

    HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

    FDA 510(k)
    FDA Class 1 ·Dental

    PROTOCO2L INSUFFLATOR MODEL 6400

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

    BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·September 21, 2023

    AVEA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 17, 2015

    BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 21, 2022

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 28, 2025

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2026

    BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·September 7, 2023

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 9, 2013

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 25, 2011

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 8, 2008

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 1, 2020

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013