8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
PAP RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
FDA 510(k)
FDA Class 2
·Dental
CPT Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
VARIO-CUP
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KWY·June 13, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 21, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 22, 2015
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