BEUDAMED
    17 results · 22ms · 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.

    Caphosol Artifical Saliva Tablets

    FDA 510(k)
    FDA Unclassified ·Unknown

    FAAC-4 - UP Facilities - 4-Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588121673·FAAC-4 - UP Facilities - 4-Shelf Cabinet

    SOYALA SILKGEL FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LO-50 LED LIGHT SOURCE

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

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 2, 2018

    NEXGEN STEMMED TIBIAL PLATE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·June 6, 2013

    HIP FRACTURE STEM #1

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWL·July 7, 2011

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 15, 2008

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 4, 2015

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 10, 2018

    TFNA FEM NAIL Ø10 R 125° L320 TIMO15

    FDA Adverse Event
    Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018

    10MM/125 DEG TI CANN TFNA 200MM - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018

    UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·September 30, 2020

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·September 30, 2020

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 9, 2016

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024