9 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·February 5, 2020
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm, 010-125-1606/Small 25 Degree 16mm X 6mm, 010-125-1808/Small 25 Degree 18mm X 8mm, 010-207-1007/Medium 7 Degree 10mm X 7mm, 010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique, 010-207-1209/Medium 7 Degree 12mm X 9mm, 010-207-1411/Medium 7 Degree 14mm X 11mm, 010-207-1613/Medium 7 Degree 16mm X 13mm, 010-213-1206/Medium 13 Degree 12mm X 6mm, 010-213-1408/Medium 13 Degree 14mm X 8mm, 010-213-1610/Medium 13 Degree 16mm X 10mm, 010-213-1812/Medium 13 Degree 18mm X 12mm, 010-219-1406/Medium 19 Degree 14mm X 6mm, 010-219-1608/Medium 19 Degree 16mm X 8mm, 010-219-1810/Medium 19 Degree 18mm X 10mm, 010-225-1807/Medium 25 Degree 18mm X 7mm, 010-225-2009/Medium 25 Degree 20mm X 9mm, 010-307-1006/Large 7 Degree,10mm X 6mm, 010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique, 010-307-1208/ Large 7 Degree 12mm X 8mm, 010-307-1410/Large 7 Degree 14mm X 10mm, 010-307-1612/Large 7 Degree 16mm X 12mm, 010-313-1205/Large 13 Degree 12mm X 5mm, 010-313-1407/Large 13 Degree 14mm X 7mm, 010-313-1609/Large 13 Degree 16mm X 9mm, 010-313-1811/Large 13 Degree 18mm X 11mm, 010-313-2013/Large 13 Degree 20mm X 13mm, 010-319-1606/Large 19 Degree 16mm X 6mm, 010-319-1808/ Large 19 Degree 18mm X 8mm, 010-319-2010/ Large 19 Degree 20mm X 10mm, 010-325-2007/Large 25 Degree 20mm X 7mm, 010-325-2209/ Large 25 Degree 22mm X 9mm, Implant Kits containing OneLIF Interbody Cages, Name/Kit Family: Kit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm, Kit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,
FDA Enforcement
Class II
·Ongoing·Novapproach Spine, LLC·May 27, 2026
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017