3,366 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Electric Handpiece EM Hand Control Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Electronic Foot Control with Direction Switch Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90110, 100 test kit (obsolete), manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·March 15, 2010
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90112, 50 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90115, Beckman test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·February 9, 2009
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·July 18, 2008
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·November 4, 2008
diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·August 20, 2010
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90116, 250 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·October 29, 2009
PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·July 18, 2008
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
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
V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
FDA Recall
Terminated
·Neo Medical, Inc.·Product code LRS·April 5, 2011