BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20237541·Steel arches Straight-Arch-F. max. .021"x.025"

    NICOLET PIONEER TC8080

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMUNETICS C6 LYME ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 29, 2019

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    TI VECTRA-ONE PLATE 2 LEVEL/32MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWQ·March 27, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 18, 2011

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·March 24, 2008

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018