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Olympus America Inc.

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed t recall (Z-2807-2015)Olympus America Inc.2015-09-22
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi st recall (Z-0432-2014)Olympus America Inc.2013-12-05
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove bl recall (Z-0329-2014)Olympus America Inc.2013-11-15
Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use recall (Z-1277-2013)Olympus America Inc.2013-05-08
Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile recall (Z-1160-2012)Olympus America Inc.2012-03-05
Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA220 recall (Z-0828-2012)Olympus America Inc.2012-01-20
Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22 recall (Z-0829-2012)Olympus America Inc.2012-01-20
Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic recall (Z-0806-2012)Olympus America Inc.2012-01-18
Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjun recall (Z-0747-2012)Olympus America Inc.2012-01-13
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Ne recall (Z-0029-2012)Olympus America Inc.2011-10-07
OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for us recall (Z-3102-2011)Olympus America Inc.2011-08-31
Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olym recall (Z-2642-2010)Olympus America Inc.2010-10-01
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/ recall (Z-2236-2010)Olympus America Inc.2010-08-18
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in recall (Z-1163-2010)Olympus America Inc.2010-03-18
Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, I recall (Z-0105-2008)Olympus America Inc.2007-10-31
Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America, I recall (Z-0106-2008)Olympus America Inc.2007-10-31
Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, I recall (Z-0107-2008)Olympus America Inc.2007-10-31
Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc. recall (Z-0108-2008)Olympus America Inc.2007-10-31
OLA 2500 Olympus Lab Automation Systems to include the following models (all serial number recall (Z-0322-06)Olympus America, Inc2005-12-23
Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6 recall (Z-0047-04)Olympus America Inc.2003-10-15
Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medic recall (Z-1126-03)Olympus America Inc.2003-08-12

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Every clearance here is in the API, with alerts when new ones post.