9 results
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18ms
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Sources: EU EUDAMED, US FDA
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MICROFLO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
710 PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FEMORAL IMPACTOR EXTRACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·February 15, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 22, 2010
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 29, 2014
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
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