BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020009·The ENDO CARRY-ON Procedure Kit contains all of...

    O2 Cannula

    FDA UDI
    SALTER LABS·10889483571507·Pediatric Cushion Nasal Cannula With 7 foot (2....

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752115125·AirLife™ Pediatric Cushion Nasal Cannula With 7...

    NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8

    FDA 510(k)
    FDA Class 2 ·Neurology

    DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STEFFEE PLATE AND SCREW

    FDA Adverse Event
    Injury ·ACROMED CORP.·Product code MCV·November 23, 1994

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·March 13, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 1, 2013

    FORTE CER FM HD D28/+3.5 12/14

    FDA Adverse Event
    Injury ·.·Product code JDI·June 2, 2020

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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