3 results
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6ms
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Sources: EU EUDAMED, US FDA
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
FDA Enforcement
Class II
·Ongoing·Saranas, Inc.·September 14, 2022
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021