4 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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VIDAS FSH, REF 30407-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·July 4, 2018
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·April 9, 2025