15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
FDA 510(k)
FDA Class 2
·Neurology
11G BLADED MAMMOTOME ST PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code KNW·February 27, 2006
Single Use Grasping Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006
MAMMOTOME HARDWARE HOLSTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·June 13, 2006
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
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