9 results
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6ms
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Sources: EU EUDAMED, US FDA
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·February 11, 2026
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·March 4, 2026
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·March 4, 2026
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·November 2, 2022
EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·October 18, 2023
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·October 7, 2020
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·October 7, 2020
Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Enforcement
Class II
·Ongoing·Rebiscan, Inc.·November 9, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022