9 results
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7ms
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Sources: EU EUDAMED, US FDA
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
FDA Enforcement
Class I
·Terminated·Stryker Sustainability Solutions·July 27, 2016
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
FDA Enforcement
Class I
·Terminated·Respironics California Inc·June 26, 2013
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·May 31, 2017
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·May 31, 2017
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019