17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814305·GENUMEDI PT SILVER R VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII
REDONDO-L
FDA 510(k)
FDA Class 2
·Orthopedic
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NEEDLE 20X1-1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 12, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code LWP·January 13, 2014
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·May 23, 2013
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·June 29, 2011
TPRLC 133 T1 PPS HO 14X148MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·April 8, 2025
TPRLC 133 MP TYPE1 PPS HO 17.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 8, 2025
TPRLC 133 T1 PPS HO 14X148MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·April 8, 2025
TPRLC XR MP T1 PPS 17X119MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 8, 2025
TPRLC 133 T1 PPS HO 17X154MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·April 8, 2025
TPRLC 133 T1 PPS HO 17X154MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·April 8, 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