11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KAINOS+
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036065614·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776362577·Periosteal Elevator
TERUMO NEEDLE WITH LOCKING SHEATH
FDA 510(k)
FDA Class 2
·General Hospital
MYALLERGYTEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
NEXUS AND NXT DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·April 21, 2009
EDWARDS TRANSCATHETER TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 3, 2020
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 2, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 15, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 16, 2011
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