BEUDAMED
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    THE LENS OR OMMI-GARD

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Trial Tibial Augment

    FDA UDI
    ADLER ORTHO SPA·08056269044141·TRIAL PANTHEON TIBIAL AUGMENT RM/LL SIZE 1 H5

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    KEYSTONE HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART FR3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 11, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·October 22, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 12, 2010

    BD PLATE CAMPYLOBACTER SB 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008

    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010

    CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010

    CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010

    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010

    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010

    Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014

    Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014

    Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008

    Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTS·February 5, 2008