16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
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
ARCHER SUPER STIFF GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
FDA 510(k)
FDA Class 2
·Hematology
MUST MINI ROD TI 3.5 X 80MM (STERILE)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021
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
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 21, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·June 14, 2013
MARK 1
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FSA·September 17, 2008
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
MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018
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