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

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    MODIFICATION TO RAPID DRUG SCREEN 9-PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AirLife

    FDA UDI
    Carefusion Corporation·10885403039171·Airlife™ Misty Max 10™ Nebulizer Wi...

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103711·BRACKET MEDIUM TWIN MAND LEFT CUSPID 022 TQ=0 A...

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·WALDEMAR LINK GMBH & COMPANY·Product code NTG·September 29, 2011

    QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEYER-SCHULTE BREAST IMPLANT

    FDA Adverse Event
    Injury ·V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·June 10, 1994

    BREAST IMPLANT

    FDA Adverse Event
    Injury ·MCGHAN MEDICAL CORP.·Product code FTR·June 10, 1994

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 12, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·February 16, 2011

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024