12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIAC PHASED ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Powder Free Nitrile Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
SYNTHES VECTRA-ONE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·April 14, 1997
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 30, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 27, 2011
UNKNOWN DEPUY SZ 3 RP TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·July 31, 2014
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