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

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    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVOTECH™

    FDA UDI
    ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037000449·Connector Tube, Yellow

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038689·VERTEK-BUSHING, FOR 2.7MM DRILL

    CRIMPING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051423·CRIMPING FORCEPS

    WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GSP NEONATALGALT KIT, MODEL 3303-001U

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Injury ·BETA BIONICS INC.·Product code QFG·November 25, 2025

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    ULTAMET MTL INS NEUT 36MM 52OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON·Product code HET·May 25, 2011

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    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