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Olympus Corporation of the Americas

317 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) o recall (Z-1616-2023)Olympus Corporation of the Americas2023-05-19
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 sc recall (Z-1418-2023)Olympus Corporation of the Americas2023-04-20
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower dige recall (Z-1132-2023)Olympus Corporation of the Americas2023-02-13
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) recall (Z-1103-2023)Olympus Corporation of the Americas2023-02-07
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S recall (Z-0424-2023)Olympus Corporation of the Americas2022-12-07
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of t recall (Z-0078-2023)Olympus Corporation of the Americas2022-10-12
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1813-2022)Olympus Corporation of the Americas2022-09-26
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1814-2022)Olympus Corporation of the Americas2022-09-26
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1815-2022)Olympus Corporation of the Americas2022-09-26
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound i recall (Z-1034-2022)Olympus Corporation of the Americas2022-05-05
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V recall (Z-0379-2022)Olympus Corporation of the Americas2021-12-10
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., auto recall (Z-1929-2017)Olympus Corporation of the Americas2017-02-21
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector recall (Z-0138-2017)Olympus Corporation of the Americas2016-10-19
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument ha recall (Z-0757-2016)Olympus Corporation of the Americas2016-02-04
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA recall (Z-0403-2016)Olympus Corporation of the Americas2015-12-10
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection betwe recall (Z-0113-2016)Olympus Corporation of the Americas2015-10-08
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time u recall (Z-2818-2015)Olympus Corporation of the Americas2015-09-28
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