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

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    Innova Nasal Non-Vented Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    6PW - CPRotector® ONE Deluxe - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA

    Cal OSHA - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal

    FLEXCERA BASE

    FDA Adverse Event
    Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

    RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AUDIT MICROCV IMMUNOASSAY LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

    CLEARLINK CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2023

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 24, 2022

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 4, 2022

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 24, 2022

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·October 16, 2008

    KAPPA 900 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·July 3, 2013

    COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·November 22, 2021

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 14, 2022

    Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code LKF·October 31, 2012

    Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code LKF·October 31, 2012

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026