7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HDL PRECIPITATING REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PUMP INFUSION WEARABLE INFUSION PUMP
FDA 510(k)
FDA Class 1
·Microbiology
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
FDA 510(k)
FDA Class 2
·Ophthalmic
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·June 12, 2014
I-STAT CHEM 8+N CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD·Product code GKF·November 3, 2010
STANDARD IM NAIL
FDA Adverse Event
Injury
·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·December 21, 2012
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