11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Argen Clear Aligner
FDA 510(k)
FDA Class 2
·Dental
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
E.S TECK ( ELECTRO SENSOR TECK)
FDA 510(k)
FDA Class 2
·Cardiovascular
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
BLACKMAX-NEURO LOW PRESSURE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 17, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013
UNKNOWN GENERATOR
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·April 7, 2021
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