BEUDAMED
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    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

    FDA Enforcement
    Class II ·Terminated·Tearscience, Inc·March 29, 2017

    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

    FDA Enforcement
    Class II ·Terminated·Tearscience, Inc·October 26, 2016

    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

    FDA Recall
    Terminated ·Tearscience, Inc·Product code ORZ·September 13, 2016

    Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio

    FDA Recall
    Terminated ·Gebauer Company·Product code LFD·January 19, 2007

    Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.

    FDA Recall
    Terminated ·Gebauer Co·Product code LFD·February 23, 2004

    SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

    FDA Recall
    Terminated ·Sunstar Americas, Inc.·Product code LFD·February 18, 2021

    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

    FDA Recall
    Terminated ·GlaxoSmithKline, LLC.·Product code LFD·October 17, 2013

    Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.

    FDA Recall
    Terminated ·Kingswood Laboratories, Inc·Product code LFD·April 22, 2005

    Endotine Transbleph 3.5 (CFD-080-0167)

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·August 3, 2016

    Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code OWB·November 21, 2013

    Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·January 1, 2014

    Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

    FDA Recall
    Terminated ·Alcon Research, Ltd·Product code LQJ·September 2, 2005

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Recall
    Terminated ·Zimmer Surgical Inc·Product code GFD·May 7, 2013

    Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Recall
    Terminated ·Zimmer Surgical Inc·Product code GFD·July 4, 2016

    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014

    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    FDA Recall
    Terminated ·KCI USA, INC.·Product code GFD·November 19, 2014

    Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Recall
    Terminated ·Zimmer Surgical Inc·Product code GFD·July 4, 2016

    Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Recall
    Terminated ·Zimmer Surgical Inc·Product code GFD·July 4, 2016

    Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437

    FDA Recall
    Terminated ·Clark Research and Development Inc Number·Product code FLD·January 19, 2007