BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    K2M MODULAR HOOKS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131262059·H110, RITE 312 WL CBE HHM

    WESTCOTT TENOTOMY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896014565·WESTCOTT TENOTOMY SCISSORS CURVED HEAVIER BLUNT...

    ADDplus

    FDA UDI
    Ulrich GmbH & Co. KG·04052536007325·Sleeve for CS 1334-01

    PORTABLE SLEEP DATA RECORDER (PSDR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELECSYS DHEA-S CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NEOCIS GUIDANCE SYSTEM

    FDA Adverse Event
    Injury ·NEOCIS INC.·Product code PLV·September 13, 2019

    OSCILLATING SAW ATTACHMENT III

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFA·October 1, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 29, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·June 14, 2011

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015