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

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    PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942142439·ENDO-COLON KIT

    N/A

    FDA UDI
    MEDTRONIC NAVIGATION, INC.·00721902672347·CLAMP 961580 SURETRAK2 LARGE

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108161·CASTROVIEJO NEEDLE HOLDER CVD W/ LOCK

    NA

    FDA UDI
    MEDTRONIC NAVIGATION, INC.·00763000337254·ACC 961-580 SURETRAK2 LARGE CLAMP

    N/A

    FDA UDI
    MEDTRONIC NAVIGATION, INC.·00721902467691·CLAMP 961-580 ACC SURETRAK2 - LARGE

    ECLIPSE WAX REMOVER

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier Sealant

    FDA 510(k)
    FDA Class 2 ·Dental

    SURETRAK® II UNIVERSAL TRACKER, LARGE CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013

    ACC 961-580 SURETRAK2, LARGE CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·July 22, 2019

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 16, 2014

    PINNACLE 100 ACET CUP 54MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 14, 2013

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code FGE·January 14, 2011

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 24, 2021

    OSS TIBIAL POLY BEARING 12MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2020

    SELEX/MAGNUM MOD HD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 15, 2018

    MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 15, 2018

    SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·December 3, 2014

    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 6, 2016