50 results
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16ms
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Sources: EU EUDAMED, US FDA
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Surgical, Inc.·May 24, 2017
Easy Diagnost Eleva Universal Fluoroscopic applications
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·December 11, 2013
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
FDA Enforcement
Class II
·Terminated·SenTec AG·November 9, 2022
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 27, 2012
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
FDA Enforcement
Class II
·Terminated·Kinsman Enterprises Inc·October 27, 2021
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 11, 2013
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·February 13, 2013
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·June 18, 2014
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 25, 2012
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·August 22, 2012
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·May 2, 2018
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 19, 2019
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 25, 2012
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 31, 2012
*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 6, 2016
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
FDA Enforcement
Class II
·Terminated·Precision Medical, Inc.·November 25, 2015
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 4, 2013