8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IV START KITS
FDA 510(k)
FDA Class 1
·General Hospital
DYNATRON IBOX IONTOPHORESIS DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
Arthrex iBalance Patella Implant, Dome
FDA 510(k)
FDA Class 2
·Orthopedic
REDUCTION FORCEPS WITH SERRATED JAWS-SOFT LOCK
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTD·July 5, 2020
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
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