11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BEDSIDE BUTLER
FDA 510(k)
FDA Class 2
·Physical Medicine
CONTOUR ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
FASHION FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·September 14, 2016
SINGLE USE ROTATABLE CLIP FIXING DEVICE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GDO·May 8, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·December 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 10, 2013
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·September 14, 2016
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·September 14, 2016
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·September 14, 2016
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024