BEUDAMED
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    AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    DSQ Alert HT Norovirus GII Primer Mix ASR

    FDA UDI
    Elitechgroup Mdx LLC·03661540952869·Product Description DSQ Alert® HT Norovirus GII...

    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

    MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 8, 2014

    INVANCE MALE SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 17, 2012

    AGILITY POST AUG TALAR SZ 4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSN·August 10, 2010

    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ILH·August 18, 2023

    PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRS·March 22, 2017

    Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower

    FDA Recall
    Terminated ·North Coast Medical Inc 8100 Camino Arroyo·Product code IKX·March 20, 2012

    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HSB·March 16, 2026

    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ITX·August 27, 2021

    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code LXH·June 29, 2020

    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ITX·August 27, 2021

    RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024

    STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

    CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016