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

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    ELECSYS CK-MB STAT IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574985·CoRoent Ant TLIF Ti, 14x10x40mm 4°

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138109902·DELUXE POST-OP SHOE MALE XLARGE

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158217621·FORCEPS JEWELER FIG. 4 .2MM TIP 4.25"

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180183704·FORCEPS, JEWELLER FIG. 4, 11CM, 0.2MM

    ASCENDX VCF REDUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·February 25, 2015

    ADJUSTABLE SPACER BLOCK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 31, 2013

    0.8% RESOLVE PANEL A

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·June 12, 2008

    DUROM US ACETABULAR COMPONENT 58/52 R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 16, 2011

    REUSABLE ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 25, 2015

    PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. 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

    Magnetom Trio MRI System, Model 7387074

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·July 28, 2004

    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017