BEUDAMED
    53 results · 25ms · Sources: EU EUDAMED, US FDA

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    Percusys® Plus Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013

    COAGUCHEK ® S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·August 5, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    AZUR VASCULAR PLUG 8

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·March 29, 2022

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 13, 2020

    CMK OC - RASP S303

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 28, 2026

    CMK OC - RASP S303

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 28, 2026

    CMK OC - RASP S202

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    CMK OC - RASP S302

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    CMK OC - RASP S303

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 28, 2026

    CMK OC - RASP S302

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    CMK OC - RASP S401

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    CMK OC - RASP S303

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·January 28, 2026

    CMK OC - RASP S304

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    CMK OC - RASP S302

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023