11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BONDING RESIN PRODUCT LINE
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102275·DALK CORNEAL DISSECTOR
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLIDE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPER MULTIVAC 50 WITH INTEGRATED CABLE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·April 16, 2008
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
MBT CEM KEEL TIB TRAY SZ4
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code NJL·January 28, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·December 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·February 1, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015