BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·November 5, 2014

    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 22, 2022

    Model No. CYF-5, Cystonephrofiberscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-5R, Cystonephrofiberscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.

    FDA Enforcement
    Class II ·Ongoing·SunMed Holdings, LLC·November 29, 2023

    Visera Hysterovideoscope Olympus HYF Type V

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·September 6, 2023

    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·March 4, 2026