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

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    TruSPECT Radiological Image Processing Station

    FDA 510(k)
    FDA Class 2 ·Radiology

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180501108·Battalion, LLIF, 4th Blade w/ Large Handle, 12m...

    NEXXT MATRIXX Stand Alone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    SPLENDOR X

    FDA Adverse Event
    Injury ·BIOS SRL·Product code GEX·August 11, 2025

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026