10 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
FDA 510(k)
FDA Class 2
·Dental
DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER
FDA Adverse Event
Injury
·Product code GCJ·June 20, 2006
GCE704 Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PIN, HIP, KNOWLES
FDA 510(k)
FDA Class 2
·Orthopedic
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FZM·August 5, 2015
COYOTE¿ ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·February 21, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 28, 2011
PROXIMATE I L S INTRALUMINAL STAPLER
FDA Adverse Event
Malfunction
·EES-ALBUQUERQUE·Product code GAG·June 5, 1997
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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