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

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    LITE-MED LM-9200 ELMA

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

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551000372·CRW BUSHING FOR 2.4MM DRILL, 95.5MM LENGTH

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795137081·3.2mm R3ACT Drill Bit, 17mm Calibrated, AO Quic...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026417·PLATEAU Interbody, Straight, Bulleted, 10mm 32m...

    PLATEAU-TL

    FDA UDI
    Life Spine, Inc.·00190837028725·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...

    HERMES PORT EXPANDER

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

    LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 14, 2020

    AVEA VENTILATOR

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

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·September 16, 2016

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 9, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·May 25, 2011

    PUMP MMT-511LNAS PRDGM INS SK EN US LN

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

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·December 29, 2015

    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

    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

    Artis Q floor, Model Number 10848280

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024