10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
UTERINE VACUM ASPIRATING CURRETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)
CLOUD CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
ICESENCE 3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·November 29, 2017
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 9, 2014
SOFPORT ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·October 19, 2012
INNERVISION SNAP SHUNT VENT CATH, BIOGLIDE, 5CM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·August 4, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020