67 results
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Sources: EU EUDAMED, US FDA
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OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
FDA Enforcement
Class II
·Terminated·Capintec Inc·September 12, 2012
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
FDA Recall
Terminated
·Resmed Corporation·Product code BZD·July 12, 2016
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Enforcement
Class II
·Terminated·Lockheed Martin Gyrocam Systems, Inc.·February 20, 2013
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
FDA Enforcement
Class I
·Terminated·CareFusion 203, Inc.·October 1, 2014
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Recall
Terminated
·Lockheed Martin Gyrocam Systems, Inc.·Product code REX·January 21, 2010
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).
FDA Recall
Terminated
·Product code CBK·September 12, 2011
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
FDA Recall
Terminated
·Product code CBK·August 8, 2014
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Terminated
·Product code CBK·January 8, 2010
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code NLH·December 17, 2018
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
FDA Enforcement
Class I
·Terminated·CareFusion 203, Inc.·July 25, 2012
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
FDA Recall
Terminated
·Product code CBK·June 19, 2012
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2015
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·November 4, 2015
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
FDA Enforcement
Class II
·Terminated·Agfa N.V.·October 3, 2018
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
FDA Enforcement
Class II
·Terminated·Barco N.V.·December 12, 2018
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.
FDA Enforcement
Class III
·Terminated·Agfa N.V.·March 27, 2019