15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
CONICAL CONNECTION IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SC SIZE 3/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 6, 2019
LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 29, 2024
LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020
LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·August 12, 2020
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017
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