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

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    MICRORATE PLUS INTELLIGENT PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pyramesh® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978081083·MESH 905-611 PYRM 16MM X 11MM ROUND

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111121739·RECAMIER CURETTE SH 12.5" #0

    Pyramesh® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856588·MESH 905-611 PYRM 16MM X 11MM ROUND

    SHEPPERD DILATATION TUBE SET (GS-501-20-H)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR

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

    GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 22, 2023

    BIOPSY FORCEPS (RADIAL JAW 4)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code FCL·June 1, 2007

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code DXY·July 1, 2014

    Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·July 31, 2019

    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021