BEUDAMED
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    TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304213951·

    5530 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136026244·3L 5530 SYR NSPIRE 2X ID TPRS

    MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMPELLA CONTROLLER WITH FLOW CONTROL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BI-METRIC CDH POR N/C 7X114

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·February 28, 2019

    M2A 38MMX56MM CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 28, 2019

    M2A 38MM MOD HD -6MM NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 28, 2019

    BI-METRIC CDH POR N/C 7X114

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 27, 2019

    TITANIUM SCREW LOW PROF 5X30MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 27, 2019

    TITANIUM SCREW LOW PROF 5X35MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 27, 2019

    ARCOM 28MM RNGLOC LNR HWALL 23

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 20, 2018

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR LLC·Product code OBR·May 1, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 15, 2013

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·June 3, 2011

    R3 XLPE INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

    TITANIUM SCREW LOW PROF 5X25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 27, 2019

    TITANIUM SCREW LOW PROF 5X25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 27, 2019

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024