71 results
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7ms
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Sources: EU EUDAMED, US FDA
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·May 21, 2025
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·June 15, 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
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
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
FDA Enforcement
Class II
·Ongoing·Cook Inc.·December 29, 2021
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·November 27, 2024
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
FDA Enforcement
Class II
·Ongoing·Cook Medical Llc·January 24, 2024
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
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
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
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·May 28, 2025
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·May 28, 2025
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