14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
4plus6Line Abutment System
FDA 510(k)
FDA Class 2
·Dental
ProLift
FDA UDI
Life Spine, Inc.·00190837105730·Static Expandable Cage Trial, 12mm x 28mm x 14m...
COMFOR TOT ARM SLING XS
FDA UDI
Bird & Cronin, LLC·20610570183634·
VACUTRON
FDA UDI
Allied Medical, LLC·00026072008638·CONTINUOUS / INTERMITTENT SUCTION REGULATOR
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
STAR 50 MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
MICROCOOL
FDA Adverse Event
Malfunction
·KIMBERLY CLARK·Product code FYA·April 17, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·June 29, 2011
BD ANGIOCATH IV CATHETER 20GA 1.88IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020
BD INSYTE¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·March 20, 2018
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 15, 2026
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