NVN - BEUDAMED

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

FDA Recall

Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

FDA Recall

Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

FDA Enforcement

Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

FDA Enforcement

Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

FDA Enforcement

Class II ·Terminated·Paragon 28, Inc.·December 18, 2019

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

FDA Recall

Terminated ·Paragon 28, Inc.·Product code PLF·September 28, 2018

VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

FDA Recall

Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

FDA Recall

Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

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-RESTA patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaintsWhole 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.comNIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.USA-002 Rev A***" Printed marketing brochure

FDA Recall

Terminated ·Non-Invasive Monitoring Systems, Inc.·Product code IRO·May 7, 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 THERAPEUTICSAt 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.comNIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.US-001 Rev A***" Printed marketing brochure

FDA Recall

Terminated ·Non-Invasive Monitoring Systems, Inc.·Product code IRO·May 7, 2012

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-RESTA patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaintsWhole 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.comNIMS, 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 THERAPEUTICSAt 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.comNIMS, 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

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

FDA Enforcement

Class II ·Terminated·Agfa Healthcare NV·October 17, 2018

ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

FDA Recall

Terminated ·CooperVision Inc.·Product code MVN·August 28, 2009

CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

FDA Recall

Terminated ·DePuy Spine, Inc.·Product code NDN·April 17, 2013