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 ×

    STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK

    FDA 510(k)
    FDA Class 2 ·Immunology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496060369·MARILYN 140 SHEER OPEN TOE, SIZE L, CIPRIA, GRA...

    CLARIS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XIA LP POLYAXIAL SCREW 6.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    XIA ROD DIA. 6 X 480

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    XIA LP POLYAXIAL SCREW 5.5 X 45MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016

    XIA POLYAXIAL SCREW 8.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011

    RINGLOC RIMCUP SHELL

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017

    LAMITRODE 44

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 11, 2013

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 15, 2011

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·June 11, 2008

    MIH MOD CUP INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017

    XIA LP POLYAXIAL SCREW 6.5 X 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022