54 results
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Sources: EU EUDAMED, US FDA
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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
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code EZY·October 28, 2024
Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
FDA Recall
Terminated
·Elan Diagnostics, Inc.·Product code CHH·November 7, 2002
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
MVP-10 Pediatric/ Neonatal Volume Ventilator
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code MNT·November 7, 2003
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
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·December 23, 2021
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
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
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
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·November 17, 2023
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
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