17 results
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9ms
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Sources: EU EUDAMED, US FDA
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
FDA Enforcement
Class II
·Terminated·Espiner Medical Ltd·November 21, 2018
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·May 25, 2016
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 nm - 1060 nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·July 25, 2018
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020