8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COULTER DART ALT (GPT) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sterngold Implant System Guided Drill 2.7mm x 14mm
FDA UDI
STERNGOLD DENTAL LLC·00841549118715·Used to generate the bore into the bone into wh...
B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFIED IVT PERIPHERAL ATHERECTOMY
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 16, 2010
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015