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

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    POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306818653·Malleable Retractor 2" x 12" w/ Protective Edge

    ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INFANT LIMB HOLDER, MODELS 306080 & 306081

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DREAMWEAR

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 7, 2025

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 8, 2011

    PROGLIDE

    FDA Adverse Event
    Injury ·ABBOTT LABORATORIES·Product code MGB·April 25, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 23, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGA·June 1, 2011

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 31, 2013

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

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