17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VINTAGE ZR
FDA 510(k)
FDA Class 2
·Dental
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HUDSON ET TUBE, SHER-I-BRONCH, RS, 35 FR
FDA Adverse Event
Malfunction
·Product code CBI·June 7, 2021
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·September 23, 2024
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013
CVC KIT: 2-LUMEN 5 FR X 55 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code LJS·March 2, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 21, 2008
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·November 27, 2024
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·November 12, 2024
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·October 2, 2024
TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·October 12, 2023
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·September 23, 2024
TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·August 8, 2023
TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·October 26, 2023
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 2, 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