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

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    NSI HEXED AND NON-HEXED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Safco Micro Applicators

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310206173·Safco endo nano applicator black POD

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162214·Channels Flex Gutta Percha Points 30.06

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108474·College Pliers 6", Self-Locking Serrated Tips

    16PW - Marathon Petroleum LS Terminals

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588206172·16PW - Marathon Petroleum LS Terminals

    SPIFE IFE CALIBRATOR AND CONTROL KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PERIFORM PERINEOMETRIC PROBE, MODEL 8300

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LEF

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·February 10, 2011

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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