14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BACI 6 -ADRENOCORTICOTROOP HORMONE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100125·KIT, TORK w' COMBAT GAUZE - ODG
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·FIBREL
HEMORAM/AGGRAM ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
STALIF C; STALIF C-Ti
FDA 510(k)
FDA Class 2
·Orthopedic
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·FIBREL
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·FIBREL
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·FIBREL
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·FIBREL
BABY CONTROL MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·June 4, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2010
NONE
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·November 26, 2012
LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code BTM·December 23, 2003
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012