8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PERSONAL BODY MASSAGER, MODELS 1605 & 1606
FDA 510(k)
FDA Class 1
·Physical Medicine
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEPSTRIP II
FDA 510(k)
FDA Class 2
·Anesthesiology
CUSTOM PAK
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code KYG·January 9, 2013
SUPER POLIGRIP (ORIGINAL AND UNKNOWN)
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·November 4, 2010
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 3, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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