BEUDAMED
    83 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Winco Nocturnal Elite Care Cliner - 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 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

    Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

    FDA Enforcement
    Class II ·Ongoing·SEDECAL SA·January 31, 2024

    Vivoo Protein Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Vivoo pH Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Vivoo Vaginal pH Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Menopause Test Cassette (Urine)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    S. Typhi/Para Typhi A Antigen

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Male Fertility Sperm Test for Home Use (Cassette)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    LH One Step Ovulation Test Device (Urine)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·March 20, 2013

    Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    2000 Vascular with 30 Degree option

    FDA Enforcement
    Class II ·Terminated·Heritage Medical Products, Inc.·November 20, 2019

    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018

    The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·October 2, 2013

    Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 31, 2013