BEUDAMED
    120 results · 9ms · Sources: EU EUDAMED, US FDA

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

    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX, LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.

    FDA Enforcement
    Class II ·Terminated·Medtronic Heart Valves Division·December 16, 2020

    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.

    FDA Enforcement
    Class II ·Terminated·Sysmex America, Inc.·April 22, 2020

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Enforcement
    Class II ·Terminated·Mermaid Medical A/S·July 29, 2015

    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

    FDA Enforcement
    Class II ·Terminated·Penner Mfg Inc·April 1, 2015

    Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015

    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·August 26, 2015