BEUDAMED
    14 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

    FDA Enforcement
    Class II ·Ongoing·Alphatec Spine, Inc.·February 5, 2025

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Enforcement
    Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023

    (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

    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

    FDA Enforcement
    Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023

    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

    FDA Enforcement
    Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023

    NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Enforcement
    Class II ·Ongoing·MAX LUX CORP·December 8, 2021

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012

    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013