8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
FDA Enforcement
Class II
·Ongoing·Ossur H / F·October 9, 2024
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
FDA Enforcement
Class I
·Ongoing·QUIDEL CARDIOVASCULAR INC·July 12, 2023
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
FDA Enforcement
Class II
·Ongoing·Kamiya Biomedical Company, LLC·November 30, 2022
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
FDA Enforcement
Class III
·Ongoing·Abbott Molecular, Inc.·March 6, 2024
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
FDA Enforcement
Class II
·Ongoing·American Surgical Company, LLC·November 13, 2024
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 26, 2023
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025