58 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
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
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
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 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 I
·Ongoing·Alcon Research LLC·December 31, 2025
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
GEM Premier 5000 PAK; Part No. 00055407510.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360011.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026