18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SuperNO2VA Et Device
FDA 510(k)
FDA Class 2
·Anesthesiology
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONE OTUCH ULTRA
FDA Adverse Event
LIFESCAN, INC.·Product code CFR·June 23, 2003
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 30, 2026
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Injury
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018
ELECSYS 2010 DISK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 21, 2014
LUMENIS ONE
FDA Adverse Event
Malfunction
·LUMENIS, LTD.·Product code GEX·October 15, 2014
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·June 5, 2013
THINLINE II STEROX
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
ELECSYS 2010
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 5, 2014
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Death
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012