BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TANDEMHEART FEMORAL ARTERIAL CANNULA SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030795·HEAD DRAPE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450194089·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017985·Wide Jaw Punch large 15 degree up milled 3.5mm ...

    PERCLOSE PROSTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MGB·April 20, 2026

    OHMEDA MEDICAL GIRAFFE OMNIBED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MGB·May 27, 2026

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

    MP 70 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 11, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    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