BEUDAMED
    22 results · 39ms · Sources: EU EUDAMED, US FDA

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    RS BIOTECH GALAXY 'R' CO2 INCUBATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022294·The ENDO CARRY-ON Procedure Kit contains all of...

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002881·Jacobson Micro Needle Holder Round Handle

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450173978·

    SILK, NONABSORBABLE, SURGICAL SUTURES, USP

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

    AUDIOSCREENER OAE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACL TOP

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

    ACL TOP

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

    SYRINGE S2 2ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 26, 2021

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 22, 2011

    DELTA-TT ACETABULAR CUP Ø54 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LPH·August 26, 2021

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·November 13, 2023

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PPD·June 11, 2024

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024