18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Knee Systems
FDA 510(k)
FDA Class 2
·Orthopedic
MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·August 27, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·April 6, 2018
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·March 8, 2022
ELECSYS CA 19-9 CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MUST MINI ROD TI 3.5 X 80MM (STERILE)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018
MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020
OPTIMA XPN 100 CENTRIFUGE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code JQC·June 14, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 17, 2008
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019
MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·October 27, 2022
MUST MINI ROD REDUCTION DEVICE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·September 27, 2019
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·August 11, 2025
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