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

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    Surgical Mask

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

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705002641·RIGIDFIX ST Tibial Plateau Guide Frame

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127022494·Femoral Head, 36mm, 0mm, Biolox

    TLC Uni Knee Tibial Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077136·

    NUMED MULLINS PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    NEXTSTEP ARTHROPEDIX

    FDA Adverse Event
    Injury ·THEKEN COMPANIES·Product code LPH·December 22, 2017

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 30, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·August 16, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    640G INSULIN PUMP MMT-1711K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 15, 2021

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017