BEUDAMED
    48 results · 27ms · Sources: EU EUDAMED, US FDA

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    PATHASSIST LIGHT FIBER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818120962·BIO 3.5 Ti Blank

    G4 SLEEVED NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMBU ASCOPE 2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2023

    CUSTOM TKR

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014

    SPECIAL TKR

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014

    CUSTOM DISTAL FEMUR IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014

    CUSTOM SMILES TKR IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014

    CUSTOM SMILES TKR

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014

    SPECIAL TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 25, 2014

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·January 25, 2018

    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

    CUSTOM SMILES TOTAL KNEE REPLACEMENT (TKR)

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014

    CUSTOM DISTAL FEMUR IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014

    CUSTOM DISTAL FEMUR IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014