7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
IV START KIT CUSTOM SMP # A-Z
FDA 510(k)
FDA Class 2
·General Hospital
OSSEOFLEX SB INFLATABLE BONE TAMP
FDA 510(k)
FDA Class 2
·Orthopedic
FASTPACK TESTOSTERONE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LINOX SMART SD 60/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO KG·Product code LWS·January 15, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015