11 results
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28ms
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Sources: EU EUDAMED, US FDA
KLEIN MICRO-CANNULA(TM)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020077·Steerable Decapolar Catheter, Multi-Purpose D C...
SURE-T PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FRN·December 9, 2020
ANY PLUS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICOR CONDUCTION CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022
CUSA EXCEL 36 KHZ CURVED EXTENDED STANDARD TIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES IRELAND LIMITED·Product code LFL·May 5, 2014
SENSIA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·November 17, 2010
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·January 8, 2013
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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