ClearanceBrief
Product code GBK

GBK

0510(k)s in 12 months (0 all time)
0recalls in 12 months (19 all time)
0recalls that name a 510(k)
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Top companies in GBK

Company510(k)sRecalls
AGA Medical Corporation019
DateFirm and productCodeLinked 510(k)
Dec 19, 2006AGA Medical Corporation
AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. ''9-TVSP-7F-180/80'' is as follow
Terminated
GBKNone listed
Dec 19, 2006AGA Medical Corporation
Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80.
Terminated
GBKNone listed
Dec 19, 2006AGA Medical Corporation
Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DE
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER D
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER D
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER De
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Del
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,
Terminated
GBKNone listed
Dec 24, 2004AGA Medical Corporation
Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery
Terminated
GBKNone listed

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