11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WHIRLPOOL BATHING UNIT-#2001
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776123079·Bayonet Bipolar Forceps
ACUMED
FDA UDI
Acumed LLC·10806378096983·1.5mm Hex Driver Assembly
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
EVIS EXERA BRONCHOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORP·Product code EOQ·February 21, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 5, 2007
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 24, 2012
12.5MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTO·October 22, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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