10 results · 27ms · Sources: EU EUDAMED, 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