BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    O'Star Nitrile Examination Gloves Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    16PW - Los Alamos - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588130583·16PW - Los Alamos - Poly White

    STILLE Osteotomes

    FDA UDI
    Stille AB·07332339206307·OSTEOTOME ORIGINAL STILLE delicate 8 mm 21 cm 8...

    CloudVue

    FDA 510(k)
    FDA Class 2 ·Radiology

    TIGER SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KNEE-DUMMY IMPLANT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    UNKNOWN KNEE DEVICE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    UNKNOWN KNEE DEVICE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·October 24, 2014

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·August 16, 2011

    ENERGEN

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

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    DEKA SMARTPERIO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021