431 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
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
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·July 3, 2024