8 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
FDA Enforcement
Class II
·Terminated·C2 Therapeutics, Inc.·March 22, 2017
ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
FDA Recall
Terminated
·Anika Therapeutics·Product code LZP·October 8, 2003
Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use. Product Number: 780A Manufactured for Bausch & Lomb Surgical Inc., Irvin, CA
FDA Recall
Terminated
·Anika Therapeutics·Product code LZP·October 8, 2003
ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
FDA Recall
Terminated
·Anika Therapeutics, Inc.·Product code LZP·July 14, 2005
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.
FDA Recall
Terminated
·Oakworks Inc·Product code IXR·May 2, 2019
Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
FDA Recall
Terminated
·Alere San Diego dba Biosite Innovacon Hemosense Inc·Product code DJR·March 12, 2010
Healix Knotless ADV BR 5.5 Suture Anchor
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·November 4, 2019
Healix Knotless ADV BR 4.75 Suture Anchor
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·November 4, 2019