12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHASE SUCKER
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
KEY SURGICAL, INC.·10849771048746·K-Wires, Double trocar, .035-inch (0.9mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292374·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659483927·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 0.90mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM710220·K-Wire w. double end trocarpoint
0.90mm...
POWDER-FREE VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Ablation Confirmation
FDA 510(k)
FDA Class 2
·Radiology
1.5MM CORTEX SCREW SLF-TPING WITH T4 STARDRIVE RECESS 12MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·February 21, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code HXW·January 26, 2011
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014
FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 7, 2021
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