17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ID MILLENNIUM, ID MOMENTS SILICONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304232884·
Bernafon
FDA UDI
Bernafon AG·05711584053065·JU7 ITCPD, WL R BE JUNA 7
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
FDA 510(k)
FDA Class 2
·Neurology
COOLCUBE COOLPEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026
SENSOR ENLITE MMT-7008A
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 27, 2011
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025
DM CONVERTER ¿ TIN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026
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