9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
TruForm
FDA UDI
Rmo, Inc.·00885797100016·MN 1MOL BD KT STD NO/L R&L 218
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
FDA 510(k)
FDA Class 2
·Immunology
SYNTHES (USA) WRIST FUSION PLATES (WFP)
FDA 510(k)
FDA Class 2
·Orthopedic
PROFEMUR(R) HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010
DELTAPLUSH - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·April 16, 2013
FOREIGN BODY REMOVAL CONE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code GAE·June 12, 2008
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020