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Occluder, Patent Ductus, Arteriosus

FDA product code MAE · Class 3 · Unknown

28
Registered devices
1,071
Adverse events
5
Recalls
0
510(k) clearances

Devices with this code

Nit-Occlud PDA — pfm medical agAmplatzer™ — ST. JUDE MEDICAL, INC.Nit-Occlud PDA — pfm medical agAmplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Nit-Occlud PDA — pfm medical agAmplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Nit-Occlud PDA — pfm medical agAmplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.

Recent recalls

DateFirmReason
2005-09-06AGA Medical CorporationThe pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic linin
2005-09-06AGA Medical CorporationThe pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic linin
2005-09-06AGA Medical CorporationThe pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic linin
2005-09-06AGA Medical CorporationThe pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic linin
2005-09-06AGA Medical CorporationThe pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic linin

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.