7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CARDIO-PAK BASIC PUMP PACK
FDA 510(k)
FDA Class 2
·Cardiovascular
ELFCARE DEVICE, MODELS 314A THROUGH 314G
FDA 510(k)
FDA Class 2
·Neurology
CALIBER SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2015
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
Pediatric Urology Wolson Pack, REF BPPU55A
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·November 1, 2023