BEUDAMED
    29 results · 32ms · Sources: EU EUDAMED, US FDA

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    KetoSens BT Blood B-Ketone Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EarQ

    FDA UDI
    Oticon A/S·05707131351319·G30 S, BTE PP 13 2.4G 105 C091 EARQ

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111384165·REILL MICRO NH CVD 6"

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450265215·

    STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M

    FDA 510(k)
    FDA Class 1 ·Dental

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 26, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·July 24, 2008

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·June 4, 2021

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020