BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033688·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...

    INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC, MET500, MOR300, THC, X

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918001204·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...

    ADVIA® 120/2120/2120i TESTpoint High Control

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414224404·ADVIA®120/2120/2120i TESTpoint™ High Control

    MODIFICATION TO XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIEW READING STATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 3, 2013

    MICRO RECIPROCATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·March 23, 2011

    GORE DUALMESH BIOMATERIAL

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES,INC·Product code FTL·April 25, 2008

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HSB·January 22, 2017

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·May 2, 2024

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 24, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024