431 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr AQ-003600 G17151; 7.0 Fr AQ-003700 G17152
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 29, 2019
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 17, 2021
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·December 31, 2025
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·October 23, 2024
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 29, 2015
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·December 31, 2025
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
FDA Enforcement
Class II
·Terminated·Cook Vascular Inc.·April 4, 2018
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 14, 2017
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 29, 2015