8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RIM-HAEMOPHILUS 2
FDA 510(k)
FDA Class 1
·Microbiology
COMPREHENSIVE LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019
THERA-CREAM, MODEL TCT004
FDA 510(k)
FDA Class 2
·Neurology
COMPREHENSIVE REVERSE SHOULDER SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 27, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 14, 2012
POLARIS IMPLANTS AND INSTRUMENTS
FDA Adverse Event
Malfunction
·EBI, LLC·Product code HXX·September 13, 2010
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