BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304553989·

    Globe Scientific

    FDA UDI
    GLOBE SCIENTIFIC INC.·00840095601351·Cap, Snap, PE, Blue, for Flared Top Urine Tube,...

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131364·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...

    NEO / Kinetic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837036454·Bone Screw Measurement Tool

    ANEURYSM CLIPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 1, 2023

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2013

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    ARROW ARTERIAL CATH SET: 20GA X 8CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·March 2, 2018

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    EMBLEM S-ICD Model A209

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