8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FLEXIBLE VASCULAR CLAMP, VERSION 2
FDA 510(k)
FDA Class 2
·Cardiovascular
Calprest, EasyCal
FDA 510(k)
FDA Class 2
·Immunology
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025