15 results · 20ms · Sources: EU EUDAMED, US FDA

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XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40

FDA 510(k)
FDA Class 2 ·Neurology

11G BLADED MAMMOTOME ST PROBE

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.·Product code KNW·February 27, 2006

Single Use Grasping Forceps

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

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

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006

MAMMOTOME HARDWARE HOLSTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006

MAMMOTOME CONTROL MODULES

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·June 13, 2006

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

CAPSURE SENSE

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

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