31 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
FDA Enforcement
Class I
·Ongoing·MEDTECH SAS·November 3, 2021
Hintermann Series Talar Implant, Left, Size 2 REF 302112
FDA Enforcement
Class II
·Ongoing·DT MedTech, LLC·June 17, 2026
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
FDA Enforcement
Class II
·Ongoing·Medical Information Technology, Inc.·September 24, 2025
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Lem Fertility LH Ovulation Test (Strip) REF 200-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS Pregnancy Test Midstream REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
One Step Pregnancy Test REF 100-01
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
One Step Ovulation Test REF 200-01
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS Ovulation Predictor Midstream REF 200-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023