BEUDAMED
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    IQ 200 URINE ANALYZER BODY FLUIDS MODULE

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902954740·CASE 7050235 CDHL NONBRKOFF SET SCRW MOD

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199533·Modular Knee Straight Reamer - 23mm

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122753·Modular Stem 23mm x 150mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139981·

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523118007·SA Cervical Screw 3.5mm Self Tapping, 14mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523118021·SA Cervical Screw 3.5mm Self Tapping, 18mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523118038·SA Cervical Screw 3.5mm Self Tapping, 20mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523118014·SA Cervical Screw 3.5mm Self Tapping, 16mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523117994·SA Cervical Screw 3.5mm Self Tapping, 12mm

    TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 10, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·May 23, 2008

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-05023. 5 mm x 20 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 2011

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025