9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE LABELS
FDA 510(k)MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018139·K-Wire, Double Ended, Diamond Point, Diameter S...
CP SLEEVE AND RIVER SLEEVE
FDA 510(k)
FDA Class 2
·Radiology
APTUS Hand Scaphoid Plates
FDA 510(k)
FDA Class 2
·Orthopedic
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 27, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 15, 2012
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2015
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018