14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·April 23, 2025
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·April 23, 2025
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·July 3, 2024
Osteosynthesis Compression Staple EasyClip
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·November 25, 2020
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·August 11, 2021
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·August 11, 2021
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·March 8, 2023
Smart Toe II Intramedullary Arthrodesis Implant
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·May 4, 2022
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 15, 2024
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·March 15, 2023
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024