10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AEROBITRON II
FDA 510(k)
FDA Class 2
·Physical Medicine
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198482·AK3 Ultra Insert Trial Size 1, 20mm
Lacrimal Dilator
FDA UDI
KATENA PRODUCTS, INC.·00841668108642·WILDER LACRIMAL DILATOR #2
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY
TOTAL HIP, CHARNELY TYPE
FDA 510(k)
FDA Class 2
·Orthopedic
Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm
FDA 510(k)
FDA Class 2
·Anesthesiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 8, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 11, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020