BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Wright

    FDA UDI
    Provision·B504OM21300390·

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012936·AUSTIN 25 DEGREE ANGLE PICK

    NA

    FDA UDI
    Nucletron B.V.·08717213023963·Pre-Plugged Needle Set

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450186077·

    SCHILLER

    FDA UDI
    SCHILLER MEDICAL·07613365900057·SpO2 sensor for Children, for MAGLIFE Serenity

    PATHWAY STM-10 PELVIC FLOOR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MW5073661

    FDA Adverse Event
    Injury ·November 30, 2017

    BOVINE XENOSURE BIOLOGIC PATCH

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code DXZ·November 30, 2017

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ABBOTT NUTRITION - COLUMBUS·Product code LZH·May 24, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 30, 2014

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·May 5, 2011

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015