10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CM 3
FDA 510(k)
FDA Class 2
·Anesthesiology
Cabo™
FDA UDI
NEUROSTRUCTURES, INC·00841508101451·3 LEVEL PLATE 48mm
Cabo
FDA UDI
Seaspine Orthopedics Corporation·10889981160463·3 Level Plate, 48mm
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TANTALUM BEADS - RADIOGRAPHIC MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNERGY
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·May 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 31, 2012
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·June 2, 2015
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017