BEUDAMED
    21 results · 34ms · 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 ×

    CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0730000·Plate Bender, Universal

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215020408·

    Crescendo Femoral Component Cemented - CR Size 0R

    FDA UDI
    AMPLITUDE SAS·03701089524056·

    PLASMAKINETIC GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ICS MEDICAL MODEL VG-30 VIDEO GOGGLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    VIASYS

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

    M2A-MAGNUM TAPER ADAPTOR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·April 9, 2018

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 23, 2013

    PERFORMANCE PRO AMBULANCE COT

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

    TVL LEAD, RIGHT VENTRICULAR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    FREEDOM CONSTRAINED LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·June 18, 2018

    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

    UNKNOWN ACETABULAR CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 18, 2018

    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

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016