BEUDAMED
    20 results · 30ms · 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 ×

    PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780432722·ntegra® Jarit® Universal Bandage Scissors, With...

    Aira

    FDA UDI
    AIRA, LLC·00810194404047·3.25" x 11" - Paper/Blue Film Self-Sealing Ster...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450268971·

    HS Stand. Burr, Ø3.5x70, 50k

    FDA UDI
    Bien-Air Surgery SA·07630055506870·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450124659·

    STAINLESS STEEL BRIGHT ARCHWIRE

    FDA UDI
    Ortho Organizers, Inc.·00190707066635·.016 Upper Stainless Steel Bright Standard Arch...

    Forceps, Dressing, TC, acc. Wangensteen 23.0cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034020333·Forceps, Dressing, TC, acc. Wangensteen 23.0cm...

    microTargeting™ Multi-Oblique Tool Guide

    FDA UDI
    FHC, INC.·00873263005460·Multi-Oblique Platform 3.2mm Tool Guide

    POWDER FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 31, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 8, 2013

    NEXGEN KNEE STEMMED NONAUGMENTABLE TIBIA

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·May 17, 2011

    AGB+

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL·Product code DQO·August 4, 2008

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 21, 2019

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021