BEUDAMED
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    PLIX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490484206·MESH 9050414 PYRM IMPL 10MMX14MMX14MM

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000855512·MESH 9050414 PYRM IMPL 10MMX14MMX14MM

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306800696·Spencer Stitch Scissors, Straight, 9cm

    R & D DESIGNATION AP-035

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDISUL DISPOSABLE VAGINAL SPECULUM

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

    PRIMORIS HIP STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·August 5, 2016

    PRIMORIS FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·October 3, 2017

    PRIMORIS NECK PROSTH BM SZ 26

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·August 4, 2016

    PRIMORIS HIP STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·August 5, 2016

    PRMRS NCK STEM TI BM SZ 24 RSA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·June 23, 2016

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    TAPERLOC LAT COCR 10MM T1

    FDA Adverse Event
    Death ·BIOMET UK LTD.·Product code JDI·March 20, 2026

    TPRLOC COCR CMTD STEM T1 7.5MM

    FDA Adverse Event
    Death ·BIOMET UK LTD.·Product code JDI·March 20, 2026

    UNKNOWN PRIMORIS HIP

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·August 4, 2016

    PRMRS NCK STEM TI BM SZ 24 RSA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWY·April 13, 2018

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 8, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 4, 2011

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    PRIMORIS NECK PROSTHESIS TI BM SIZE 26

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·November 9, 2017