60 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 19, 2025
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·January 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.
FDA Enforcement
Class I
·Terminated·DIABETIC SUPPLY OF SUNCOAST, INC.·July 30, 2014
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023