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

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    BoneMRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    16PW - Burn Relief

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030302·16PW - Burn Relief

    Pomee

    FDA UDI
    POMEE CORPORATION·G15772330300·Shortbent stitch 3 1/2"

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113639·RETROBULBAR NEEDLE 25GA 38MM

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180163379·Pin cutter, Side cutting. Capacity 6.3mm. Overa...

    J & J INSTRUMENTS

    FDA UDI
    J & J INSTRUMENTS INC·00817524025774·SHORTBENT STITCH SCI 3.5"" CVD

    TSI Stem Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040581·

    DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FPA·August 15, 2019

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 25, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 18, 2013

    BD¿ PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 5, 2019

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    FDA Adverse Event
    Malfunction ·ZYNO MEDICAL, LLC·Product code FPA·December 2, 2020

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025