BEUDAMED
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    hygh-tec drainage

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POYA 3.5mm Posteromedial Proximal Tibia Plate, 13 Hole, Left

    FDA UDI
    Bonebridge AG·07640187462579·

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·00190660194895·Corneal trephine blade, short, 8.0mm length, 14...

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120086·G185 Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120093·Incubator for Assisted reproduction

    npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

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

    PAX-UNI3D, PHT-7500

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 3, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2013

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    XP-XP Tibial Tray - Interlok 71 mm Item # 195755

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025