77 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code KCZ·December 11, 2019
EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Epidural anesthesia kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010
Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.
FDA Recall
Terminated
·Product code KFZ·April 15, 2003
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
FDA Enforcement
Class II
·Terminated·Nobel Biocare Procera LLC·June 2, 2021
Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Enforcement
Class II
·Terminated·Rocket Medical Plc·December 4, 2019
Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.
FDA Recall
Terminated
·KCI USA, Inc.·Product code OMP·November 4, 2009
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
FDA Recall
Terminated
·KCI USA, INC.·Product code GFD·November 19, 2014