BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    PATHWAY PH BLOOD GAS CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REST ASSURED GENERATION III DENTAL PROTECTOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRISMAFLO

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    STRYKER CORPORATION·04546540362445·2.0mm Wire Pass Drill Bit

    NA

    FDA UDI
    STRYKER CORPORATION·04546540362414·1.3mm Wire Pass Drill Bit

    NA

    FDA UDI
    STERILMED, INC.·10888551026888·WIRE PASS DRILL FOR USE WITH TPS ELITE ATTACHMENTS

    NA

    FDA UDI
    STRYKER CORPORATION·04546540362407·1.0mm Wire Pass Drill Bit

    NA

    FDA UDI
    STRYKER CORPORATION·04546540362438·1.7mm Wire Pass Drill Bit

    NA

    FDA UDI
    STERILMED, INC.·10888551026871·DRILL WIRE PASS FOR STRYKER TPS ELITE

    NA

    FDA UDI
    STRYKER CORPORATION·04546540362421·1.5mm Wire Pass Drill Bit

    1.5MM X 10.0MM TAPERED ROUTER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·August 19, 2019

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM / ALCON N.V.·Product code KYG·April 1, 2014

    PHYSIOMESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·November 6, 2012

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·August 25, 2010

    Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code JDR·June 2, 2006

    Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 18, 2014

    Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 18, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021