13 results
·
68ms
·
Sources: EU EUDAMED, US FDA
ONE TRAY
FDA Adverse Event
Malfunction
·INNOVATIVE STERILIZATION TECHNOLOGIES LLC·Product code KCT·June 7, 2019
ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS
FDA Adverse Event
Malfunction
·INNOVATIVE STERILIZATION TECHNOLOGIES LLC·Product code KCT·May 3, 2019
ONE TRAY
FDA Adverse Event
Malfunction
·INNOVATIVE STERILIZATION TECHNOLOGIES LLC·Product code KCT·May 25, 2017
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
FDA Recall
Terminated
·Innovative Sterlization Technologies LLC·Product code KCT·February 3, 2014
Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.
FDA Recall
Terminated
·Innovative Implant Technology·Product code NDP·September 30, 2008
France Chirurgie Instrumentation SAS
Importer
🇫🇷 France·13 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Medilens Nordic AB
Importer
🇸🇪 Sweden·29 Manufacturers
Kuomed Oy
Importer
🇫🇮 Finland·21 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
FDA Enforcement
Class II
·Terminated·Innovative Sterlization Technologies LLC·October 28, 2015
MediMark Europe Sarl.
Authorized representative
🇫🇷 France·35 Manufacturers·3394 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices