11 results
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17ms
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Sources: EU EUDAMED, US FDA
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Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
FDA Enforcement
Class II
·Ongoing·Stryker Orthopaedics·June 5, 2024
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
IDM-MICRO-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Enforcement
Class II
·Ongoing·mo-Vis BVBA·January 17, 2024
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026