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

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    PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925011571·AUSTIN ATTIC DISSECTOR 4.74 MM TIP LENGTH STAIN...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003162·Left L Plate, 8mm, Rigid

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05065025111655·KLEOS 2 PSL METAL STANDARD TORQUE 022 LR3 PK5

    TISSUE FORCEPS ADSON 4 3/4" MICRO-SERRATE

    FDA UDI
    W.H. Holden, Inc.·D9281300430·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450186428·

    COROENT XLR STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH

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

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2013

    EXTRA LONG ANGLED SABER ATTACHMENT

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

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·August 19, 2008

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·February 28, 2025

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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