9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LAPAROSCOPY SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLARO 4
FDA 510(k)
FDA Class 2
·Dental
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 7, 2021
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 4, 2014
UNKNOWN LEFT HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·January 10, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 5, 2010
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015