141 results
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Sources: EU EUDAMED, US FDA
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LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·March 11, 2015
HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
FDA Recall
Terminated
·Barrx Medical, Inc.·Product code GEI·May 25, 2011
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code DRF·February 25, 2015
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·February 12, 2020
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·February 12, 2020
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
FDA Enforcement
Class II
·Terminated·Associates of Cape Cod, Inc.·May 22, 2019
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
FDA Enforcement
Class II
·Terminated·Associates of Cape Cod, Inc.·September 28, 2022
Plicator EPS Plication System Catalog Number: 160-01128R
FDA Recall
Terminated
·NDO Surgical, Inc.·Product code KOG·January 26, 2007
Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
FDA Recall
Terminated
·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022
RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
FDA Recall
Terminated
·Teleflex Medical·Product code KOD·June 30, 2011
McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the USA Urethral Catheter Tray with Plastic Catheter
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011
WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011
REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
FDA Recall
Terminated
·Convatec Inc.·Product code KOD·February 7, 2014
HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall
Terminated
·Rochester Medical Corp·Product code KOD·January 14, 2009
Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall
Terminated
·Rochester Medical Corp·Product code KOD·January 14, 2009