20 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capillus302, Capillus312, Capillus352
FDA 510(k)
FDA Class 2
·Physical Medicine
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
FDA 510(k)
FDA Class 3
·Orthopedic
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013
PTFE FELT PLEDGETS
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DXZ·July 13, 2022
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO·Product code DTB·October 10, 2014
BLACKMAX-NEURO
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HSZ·June 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012
CRE¿ WIREGUIDED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012
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