8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
3-D PASSIVE MOBILIZER
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDOWRIST ONE VESSEL SEALER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 19, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012
Vanguard XP Tibial Tray 67 mm Item # 195247
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025