BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Infrared Thermometer Model E127

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958000225·Medilas D MultiBeam Diode Laser, D-Plug

    24M - Nevada Energy - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154558896·HEMOSTATIC FORCEPS, KOCHER, DEL., CVD.

    TSO3 OZONE CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 7, 2016

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 7, 2016

    ENDO CLIP APPLIER

    FDA Adverse Event
    Injury ·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL·Product code FZP·June 26, 2014

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 3, 2020

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·October 20, 2008

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·July 29, 2011

    COBAS 8000 E602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 2, 2013

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018