12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221613000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221613070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221613150·
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837068677·Pro-Link Titanium Bi-Convex
AGILIA INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
NIVEOUS LIQUID DAM
FDA 510(k)
FDA Class 1
·Dental
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·November 3, 2014
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·August 19, 2011
INTELLIVUE TELEMETERY SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 1, 2013
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·April 1, 2024
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 8, 2018