13 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
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
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·May 8, 2024
biokitHSV-2 Rapid Test, REF: 300028001
FDA Enforcement
Class II
·Ongoing·Biokit, S.A.·February 1, 2023
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
FDA Enforcement
Class II
·Ongoing·Steris Corporation·February 14, 2024
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
FDA Enforcement
Class II
·Ongoing·Steris Corporation·February 14, 2024
Detector H. Pylori, Catalog Number IHP-30
FDA Enforcement
Class II
·Ongoing·Immunostics, Inc.·January 17, 2024
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
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
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