10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GYNECARE VERSAPOINT G-VAP ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
EPICAGE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HealthVCF
FDA 510(k)
FDA Class 2
·Radiology
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 7, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 5, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Death
·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015
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