BEUDAMED
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    Applied Medical Laparoscopic Linear Cutter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022403365·Broach, Tibial Cone, XS Full +2mm

    SYNGO CT DYNAMIC ANGIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENSITITRE AIM (TM)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MAI·December 7, 2016

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 26, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 6, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 20, 2011

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012