14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Medical Diode Laser Systems (VeinCure)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 25, 2021
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 4, 2021
Gemini Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
VYGON LEADER-FLEX
FDA 510(k)
FDA Class 2
·General Hospital
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 25, 2013
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·January 17, 2018
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·January 17, 2018
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·January 17, 2018
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014