7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HARRIS CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MED-LOGICS DISPOSABLE ALK TUBING
FDA 510(k)
FDA Class 1
·Ophthalmic
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 31, 2012
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·August 20, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025