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

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    LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162146·Channels Flex Gutta Percha Points 15.04

    HER-SPEC

    FDA UDI
    OBP CORPORATION·M648C0206100·VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE S...

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108191·Midway Select Iris Scissors 4 1/2" Straight

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450546109·

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113355·PS Insert, Size 6 x 10mm

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESOLUTION CHOLESTEROL MONITOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TESS GLENOID REVERSE HEAD DIAMETER 36

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

    FREESTYLE

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

    MINIMARK DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO., INC.·Product code DZE·March 21, 2013

    BV LIBRA 6"

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZL·February 10, 2011

    VNGD PS+ TIB BRG 10X71/75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 4, 2023

    BIOMET ILOK PRI TIB TRAY 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 4, 2023

    BMET ARCOM AP PAT 3PST 34MM MD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 4, 2023

    BIOMET FINNED PRI STM 80X12.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 4, 2023

    THE ELECTRODE STORE

    FDA Adverse Event
    Malfunction ·THE ELECTRODE STORE·Product code GXZ·July 17, 2021

    Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·August 8, 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