19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CHASE PHRENIC NERVE PAD
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
KEY SURGICAL, INC.·10849771048739·K-Wires, Double trocar, .028-inch (0.7mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659483910·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 0.70mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM710210·K-Wire w. double end trocarpoint
0.70mm...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707048631·WELDABLE LINGUAL BUTTON - CURVED
AUTO-CLIP
FDA 510(k)
FDA Class 2
·Cardiovascular
JO Agapé Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZMR®
FDA UDI
Zimmer, Inc.·00889024159006·
ZMR®
FDA UDI
Zimmer, Inc.·00889024158993·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214712·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214736·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214743·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214705·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214750·
NexGen®
FDA UDI
Zimmer, Inc.·00889024214729·
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 6, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017