56 results
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6ms
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Sources: EU EUDAMED, US FDA
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·August 27, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·March 5, 2025
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
FDA Enforcement
Class II
·Ongoing·HeartSine Technologies Ltd·October 29, 2025
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
FDA Enforcement
Class II
·Ongoing·HeartSine Technologies Ltd·July 19, 2023
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·March 5, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·March 5, 2025
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Centurion FMS Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Legion FMS Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Constellation Procedure Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Infinity FMS Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 16, 2025
Alcon Custom Pak Surgical Procedure Pack
FDA Enforcement
Class II
·Ongoing·Alcon Research, LLC·December 7, 2022
GEM Premier 5000 PAK, Part No. 00055360004.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360010.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407504.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360008.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407511.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407508.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026