BEUDAMED
    14 results · 19ms · 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 ×

    SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYSTEROSCOPES

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

    FRC POSTEC

    FDA 510(k)
    FDA Class 1 ·Dental

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN·Product code FTR·March 26, 2013

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2011

    STRATA ADJUSTABLE VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·April 2, 2008

    BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·May 31, 2019

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    HOSP SS FLEXX METER LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    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