BEUDAMED
    25 results · 13ms · Sources: EU EUDAMED, US FDA

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    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 Recall
    Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code LJX·November 22, 2025

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·December 28, 2020

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code HXC·August 14, 2019

    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·June 27, 2024

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

    FDA Recall
    Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code JJW·November 22, 2025

    Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJW·September 17, 2024

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJW·November 18, 2022

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJW·July 16, 2024

    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJW·February 16, 2022

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Recall
    Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·September 18, 2025

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024