9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
COLLINS POSITIONING DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
FDA 510(k)
FDA Class 2
·General Hospital
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
4.5MM NARROW LCP® PLATE 11 HOLES/206MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 12, 2015
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·December 10, 2012
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO·Product code KQS·September 28, 2010
TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 26, 2014
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