8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STAR BREATHING CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DIOLASE
FDA 510(k)
FDA Class 1
·Radiology
SROM STM STD 36+12L 15X20
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·January 30, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·December 21, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 4, 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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025