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

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    OHMEDA MEDICAL GIRAFFE INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Excel™ Impression Material

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310205473·Safco heavy body fast set impression material 4pk

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717107146·Gutta Percha Points, Taper .04, Size #30, 60pcs...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450258996·

    KAO HOME ENT. CO., LTD.

    FDA registration
    KAO HOME ENT. CO., LTD.·1 product·🇹🇼 Taiwan

    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ATR TECNIKA

    FDA 510(k)
    FDA Class 1 ·Dental

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·April 16, 2019

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2013

    FUSION OMNI-TOME SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·February 10, 2011

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014