9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
FDA 510(k)
FDA Class 1
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123816·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 125mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150577·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 125mm
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
FDA 510(k)
FDA Class 2
·Cardiovascular
SILKN BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 18, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 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