BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550179·GENUMEDI PT KNEE SUP SILVER R EW III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799363·MANUMED ACTIVE WRIST RIGHT SILVER M

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104356·Rod Straight 5.5 x 130mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm

    HYPERION VISIQUANT ANA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    FINESS ENDOSCOPE STERILIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·September 21, 2017

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code FZP·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    ATN AR 100 MM LENGTH

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'RL·Product code HSB·May 20, 2011

    BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018