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

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    MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GUEDEL AIRWAY, SIZE 1.5, ISO 7

    FDA UDI
    Intersurgical Incorporated·05030267050635·GUEDEL AIRWAY, SIZE 1.5, ISO 7

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm

    OptumSI Implant System

    FDA UDI
    SI Solutions, LLC·00850057247251·Sacroiliac Joint Fusion Implant, 11.5mm x 70mm

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213036277·Coupling Treatment Tube for 6F Flexibles (23)

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded

    HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013

    3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·August 15, 2017

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·May 6, 2013

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·September 23, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 2, 2011

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·May 14, 2024

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·May 14, 2024

    XP-CR Tibial Tray - Interlok 69mm Item # 195272

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021