8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
Sterngold Implant System Guided Drill 3.25mm x 6mm.
FDA UDI
STERNGOLD DENTAL LLC·00841549118722·Used to generate the bore into the bone into wh...
CHALLENGE 5000 POWERED MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
MAGNETIC RESONANCE DEVICE MRT 150A
FDA 510(k)
FDA Class 2
·Radiology
TWIST DRILL D3.8, L 310, COIL 50, QUICK COUPLI
FDA Adverse Event
Malfunction
·AAP IMPLANTATE AG·Product code HTW·May 28, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
MATTRESS SHEETS (DISPOSABLE), 46' X 84"
FDA Adverse Event
Injury
·GLOBAL HEALTHCARE·Product code KME·November 16, 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