BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    SILVERMED ANTIMICROBIAL SILVER HYDROGEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Vented Vial Adapter Transfer Device

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240313·Vial Adapter 13mm Vented FLL - VF

    Vented Vial Adapter Transfer Device

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240894·Vial Adapter 13mm Vented FLL - VF

    Symmetry Gruenwald

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482035825·Symmetry® Forceps, Gruenwald Bayonet, Serrated,...

    Cosmolock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm

    DATACAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 16, 2024

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·September 9, 2014

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 21, 2011

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·March 21, 2023

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    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