448 results · 12ms · Sources: EU EUDAMED, US FDA

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QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·August 15, 2013

Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.

FDA Recall
Terminated ·Unomedical·Product code BTM·October 6, 2009

MVP-10 Pediatric/ Neonatal Volume Ventilator

FDA Recall
Terminated ·Bio-Med Devices, Inc.·Product code MNT·November 7, 2003

Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

FDA Recall
Terminated ·TELEFLEX-MORRISVILLE·Product code BZD·June 14, 2019

SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.

FDA Recall
Terminated ·Wescor, Inc·Product code HYB·January 6, 2010

Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

FDA Recall
Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

FDA Recall
Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·June 12, 2012

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

FDA Recall
Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM.

FDA Recall
Terminated ·Unomedical·Product code BTM·October 6, 2009

Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM.

FDA Recall
Terminated ·Unomedical·Product code BTM·October 6, 2009

Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.

FDA Recall
Terminated ·Unomedical·Product code BTM·October 6, 2009

Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

FDA Recall
Terminated ·VIASYS Med Systems·Product code CAI·September 10, 2003

Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

FDA Recall
Terminated ·VIASYS Med Systems·Product code CAI·September 10, 2003

The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2.6.1 9896 030 19863-SW R 2.6.3

FDA Recall
Terminated ·Philips Medical Systems North America Co. Phillips·Product code LNH·February 5, 2010

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

FDA Recall
Terminated ·GE Healthcare, LLC·Product code LNH·November 15, 2018

EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

FDA Recall
Terminated ·Clerio Vision·Product code LPL·February 16, 2021