Company ยท US
Cook Medical Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2024. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
55recalls (0 in 12 months)
51recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2025 | Cook Medical Incorporated Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-
Reference Part Numbers
ZTA2-P-40-117-W
ZTA2-P-40-167
ZTA2-P-40-167-W
ZTA2-P-40-217-W
ZTA2-P-42-121
ZTA2-P-42-121-W
ZTA2-P-42-173
ZTA2- Open, Classified |
MIH | None listed |
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Open, Classified |
FCG | K210476 |
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Open, Classified |
FCG | K092359 |
| Jan 12, 2024 | Cook Medical Llc MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 Open, Classified |
MQG | None listed |
| Feb 14, 2022 | Cook Medical Incorporated Cook Celect PlatinumVena Cava Filter Set
Catalog Number/GPN:
IGTCFS-65-1-FEM-CELECT-PT G34502;
IGTCFS-65-1-JUG-CELECT-PT G34309;
IGTCFS-65-1-UNI-CELECT-PT G34505; Terminated |
DTK | K211875 |
| Feb 14, 2022 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Catalog Number/GPN:
IGTCFS-65-1-FEM-TULIP G52917;
IGTCFS-65-1-JUG-TULIP G52916;
IGTCFS-65-1-UNI-TULIP G52918 Terminated |
DTK | K211874 |
| Dec 16, 2020 | Cook Medical Llc Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 Terminated |
MQG | K983642 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP
Product Usage:
The Gunther Tulip Filter is intended for the prevention of recurrent pul Terminated |
DTK | K172557 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmona Terminated |
DTK | K172557 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmon Terminated |
DTK | K172557 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K043481 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | K050698 |
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