5 results
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14ms
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Sources: EU EUDAMED, US FDA
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·December 23, 2020
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 7, 2019
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 7, 2019
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
FDA Enforcement
Class III
·Terminated·AGFA Healthcare Corp.·August 20, 2014
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017