8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LACERATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bloom2 Programmable Electrophysiology Stimulator
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSITION STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
BREAST IMPLANT EXPANDER/SMOOTH ROUND SPECTRUM SALINE
FDA Adverse Event
MENTOR CORP·Product code FWM·December 11, 2012
PLM A+3 MEDNET WRLSS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 20, 2010
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021