7 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021