BEUDAMED
    25 results · 31ms · 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 ×

    AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV

    FDA 510(k)
    FDA Class 1 ·Dental

    FAS SET #4551

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

    DISPOSABLE PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 6, 2010

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 27, 2010

    SUTURE ANCHOR, BIO-CORKSCREW FT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 9, 2013

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNT·February 25, 2011

    VITALITY 2 VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 5, 2012

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 18, 2012

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 6, 2011

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 10, 2012

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 10, 2012

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 29, 2010

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 25, 2011

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

    PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    OT TEST STRIPS BLUE

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 27, 2011

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 21, 2011