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

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ARTHRO-PREP REST W/STAND

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ERA® Implant Abutment Micro 0°, 3mm Cuff (AT)

FDA UDI
STERNGOLD DENTAL LLC·00841549103506·ERA abutments provide a resilient attachment wi...

MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

FDA 510(k)
FDA Class 2 ·Anesthesiology

WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

REALSEAL

FDA Adverse Event
Injury ·SYBRONENDO·Product code KIF·May 15, 2014

EXTERNAL PULSE GENERATOR

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·August 17, 2010

TORQUE LIMITING ATTACHMENT 1.2NM

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code LXH·June 4, 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