BEUDAMED
    92 results · 21ms · Sources: EU EUDAMED, US FDA

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    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

    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.

    FDA Enforcement
    Class I ·Ongoing·Trividia Health, Inc.·March 18, 2026

    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK

    FDA Enforcement
    Class I ·Ongoing·Trividia Health, Inc.·March 18, 2026

    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12

    FDA Enforcement
    Class I ·Ongoing·Trividia Health, Inc.·March 18, 2026