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

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    BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...

    OneTouch Ultra2

    FDA UDI
    LifeScan Europe GmbH·00353885010016·OneTouch Ultra2 Blood Glucose Monitoring System...

    CHROLOY SOLDER

    FDA 510(k)
    FDA Class 2 ·Dental

    SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 27, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 24, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 2008

    BARREL 10CC LL W/SILICONE NO BD LOGO BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 30, 2020

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·August 30, 2019

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018