BEUDAMED
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    OnQ Neuro

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087076·SOLUTION SYSTEM THINSHAFT REAMER 16mm DIA

    AVIATOR PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·November 18, 2014

    MINITAC

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE·Product code MBI·August 12, 2011

    MECC AVR

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DWE·August 1, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MPRI·Product code LWS·July 8, 2013

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·April 23, 2021

    CUSA EXCEL 36KHZ TUBING SET

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·March 20, 2019

    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

    FDA Recall
    Open, Classified ·Medicalplastic S.R.L. Via Saverio Mercadante·Product code KTT·June 17, 2021

    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

    FDA Enforcement
    Class II ·Ongoing·Medicalplastic S.R.L.·November 24, 2021

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·August 26, 2009

    Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LXH·May 27, 2005

    stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology, Inc.·October 12, 2022

    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

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

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015