8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ABL 735 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Monolith
FDA UDI
Nuvasive, Inc.·00887517677167·Monolith Core, Ø14x17mm
Belun Ring
FDA 510(k)
FDA Class 2
·Cardiovascular
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 6, 2013
VIVA XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014
TRANSVENE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·February 15, 2011
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019