11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EXTRA LARGE LONG HANDLED SPONGE
FDA 510(k)
FDA Class 1
·Physical Medicine
WAVE O SPINAL SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169244627·CAGE 2761126 WAVE O 11MM X 26MM 6DEG
Kangaroo
FDA UDI
Cardinal Health, Inc.·10884521051379·Bolus Feed Set
Ceramill Sintron®
FDA UDI
Amann Girrbach AG·E4947611261·
Straumann Sintron
FDA UDI
Amann Girrbach AG·E494761126STM1·
ASAHI Corsair Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUREX
FDA 510(k)
FDA Class 2
·Radiology
INFUSO.R.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 26, 2012
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 31, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·July 15, 2010
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