452 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·February 14, 2022
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·February 14, 2022
Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code CAC·August 4, 2006
Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code CAC·August 4, 2006
dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code CAC·August 4, 2006
dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code CAC·August 4, 2006
Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs)
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE Cardiovascular, Inc..-(shipped international only for use in Heart/Lung Packs)
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 078428010, 078688007, 078869003. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
FDA Recall
Terminated
·CaridianBCT, Inc.·Product code LKN·October 26, 2011
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTN·May 9, 2003
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·October 31, 2018
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Enforcement
Class II
·Terminated·Prism Medical Services USA·June 26, 2013
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
FDA Enforcement
Class II
·Terminated·Stanley Security Solutions, Inc.·October 10, 2012