9 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Recall
Terminated
·Arc Medical Inc·Product code BYD·February 19, 2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Enforcement
Class III
·Terminated·Arc Medical Inc·May 20, 2015
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Inc.·Product code IYE·July 20, 2010
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·December 26, 2012
Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·June 27, 2011
Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes
FDA Recall
Terminated
·Healthway Home Products, Inc.·Product code FRF·January 9, 2012
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Recall
Terminated
·Cardio Medical Products·Product code LDD·April 26, 2013
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 5, 2012