120 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
FDA Recall
Terminated
·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·March 31, 2022
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
FDA Recall
Terminated
·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FBN·December 20, 2017
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code CBN·January 12, 2015
Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code GBN·October 8, 2014
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
FDA Recall
Terminated
·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·August 31, 2020
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FBN·April 6, 2016
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·December 12, 2016
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FBN·April 6, 2016
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·April 21, 2021
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·May 22, 2013
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
FDA Enforcement
Class I
·Terminated·Praxair Inc.·January 2, 2013
Stryker SmartLife Large Aseptic Housing (7126-120-000)
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 3, 2017
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·December 10, 2014
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016
Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).
FDA Enforcement
Class II
·Terminated·Medela Inc·January 8, 2020