Atlas FDA

AGA Medical Corporation

32 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch AGA Medical Corporation

RecordFirmDate
AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Natha recall (Z-1595-2011)AGA Medical Corporation2011-03-08
AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. recall (Z-1101-2010)AGA Medical Corporation2010-03-11
AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Us recall (Z-2192-2008)AGA Medical Corporation2008-09-03
AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendels recall (Z-2193-2008)AGA Medical Corporation2008-09-03
Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delive recall (Z-0255-2007)AGA Medical Corporation2006-12-19
Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) recall (Z-0256-2007)AGA Medical Corporation2006-12-19
AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. recall (Z-0257-2007)AGA Medical Corporation2006-12-19
AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm St recall (Z-0052-2007)AGA Medical Corporation2006-10-20
AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm St recall (Z-0053-2007)AGA Medical Corporation2006-10-20
AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. recall (Z-0461-06)AGA Medical Corporation2006-01-31
AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile EO. recall (Z-0462-06)AGA Medical Corporation2006-01-31
AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. recall (Z-0463-06)AGA Medical Corporation2006-01-31
AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. recall (Z-0464-06)AGA Medical Corporation2006-01-31
AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile EO recall (Z-0465-06)AGA Medical Corporation2006-01-31
AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, recall (Z-0127-06)AGA Medical Corporation2005-11-05
Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled recall (Z-0350-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as recall (Z-0351-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as recall (Z-0352-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as recall (Z-0353-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as recall (Z-0354-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as recall (Z-0355-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled a recall (Z-0356-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled a recall (Z-0357-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled recall (Z-0358-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled recall (Z-0359-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is labeled recall (Z-0360-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled recall (Z-0361-05)AGA Medical Corporation2004-12-24
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled recall (Z-0362-05)AGA Medical Corporation2004-12-24
AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled a recall (Z-0363-05)AGA Medical Corporation2004-12-24
AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled recall (Z-0364-05)AGA Medical Corporation2004-12-24
AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled recall (Z-0365-05)AGA Medical Corporation2004-12-24
AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled recall (Z-0366-05)AGA Medical Corporation2004-12-24

Track AGA Medical Corporation automatically

Every clearance here is in the API, with alerts when new ones post.