287 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ingenuity Core Model # 728321, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
Ingenuity CT, Model # 728326, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
iCT SP Model # 728311, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
Ingenuity Core128 Model # 728323, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
IQon Spectral CT Model # 728332, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
Brilliance 64 Model # 728231, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
Vereos PET/CT Model # 882446, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
iCT, Model # 728306, computed tomography x-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·October 30, 2019
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·June 1, 2015
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
FDA Recall
Terminated
·Parker Medical·Product code CBI·December 16, 2016
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·June 1, 2015
Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; sold under the following catalog numbers: a) catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, Irving, TX 75062 b) catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·February 23, 2005
Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16137
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·February 23, 2005
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·June 1, 2015
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
FDA Recall
Terminated
·Teleflex Medical·Product code CBI·June 1, 2015
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 28, 2018
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 28, 2018
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 28, 2018