8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BREAST THERMAL ACTIVITY INDICATOR
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SPEED 808 DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI-HEAT INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
PFC SIG MOD TIB TRAY CEM SZ2.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 27, 2014
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MMX12
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·October 30, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·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