8 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NYLAMID SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ALT LASER, MODEL VTR 75

FDA 510(k)
FDA Class 2 ·Physical Medicine

ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES

FDA 510(k)
FDA Class 2 ·Orthopedic

FOUNDATION KNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·January 22, 2013

VASOVIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET, INC·Product code GEI·December 1, 2010

M2A-MAGNUM MODULAR HEAD SZ 42MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 14, 2014

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

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