BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNTHES 6.0 COCR AND CPT TI-3 RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·September 16, 2016

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·December 29, 2015

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    Bernafon

    FDA UDI
    Bernafon AG·05711584003497·MD3 CP, VC PS MAC MONDO 3

    HAND SURGERY OSTEOTOME

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896052628·HAND SURGERY OSTEOTOME STRAIGHT BLADE

    NIPRO SAFELET CATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODEL K7 EVALUATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·September 19, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011

    INTERGARD KNITTED

    FDA Adverse Event
    Injury ·INTERVASCULAR SAS·Product code DSY·November 22, 2016

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR SL (Model L301)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025