3 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025