BEUDAMED
    18 results · 33ms · 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.
    Filters Regulation: Us FDA ×

    SmartTENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROULTRA PIEZO ULTRASONIC

    FDA 510(k)
    FDA Class 2 ·Dental

    20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·June 3, 2013

    CARELINK PERSONAL

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 27, 2014

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·June 29, 2011

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 7, 2020

    SOLARICE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code LOX·August 26, 2019

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019