8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
FDA 510(k)
FDA Class 2
·Immunology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665589835·MIS Fenestrated Screw M, Ø10.5 x 95mm, Ø6.0mm Rod
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
DENTAL ALGINATE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·March 5, 2013
CLARITY DDDR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DXY·August 8, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·February 15, 2011
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016