BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    REMEL XPECT FLU A&B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ThermoCool SF NAV

    FDA UDI
    Biosense Webster Inc·10846835009286·TCOOL SF CARTO XP UNI, TC, J

    Sasmar Vanilla

    FDA UDI
    Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

    COMPRESS DISTAL FEMORAL REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GIRAFFE AND PANDA WARMERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NONE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US·Product code GAM·April 30, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DPS·June 16, 2011

    DEXTRUS 4137

    FDA Adverse Event
    Death ·BIOTRONIK, GMBH AND CO.·Product code DTB·August 21, 2008

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·February 3, 2017

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·March 10, 2017

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    ACUSON

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·July 13, 2016

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JSO·July 2, 2004

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025