8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CLINIFEEDING SYSTEM 1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
BD SPINAL NEEDLE 27G
FDA 510(k)
FDA Class 2
·Anesthesiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 21, 2014
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·August 10, 2010
B105M Patient Monitor, REF 6160000-003
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021