35 results
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8ms
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Sources: EU EUDAMED, US FDA
Smart Toe II Intramedullary Arthrodesis Implant
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·May 4, 2022
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·April 9, 2025
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
FDA Enforcement
Class II
·Ongoing·Staar Surgical AG·June 24, 2026
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 24, 2026
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
FDA Enforcement
Class II
·Ongoing·Smith & Nephew Orthopaedics AG·August 26, 2020
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
FDA Enforcement
Class II
·Terminated·Stryker GmbH·March 13, 2019
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018