8 results
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6ms
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Sources: EU EUDAMED, US FDA
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·June 2, 2021
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·April 29, 2026
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·April 29, 2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·April 29, 2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·April 29, 2026