BEUDAMED
    13 results · 36ms · Sources: EU EUDAMED, US FDA

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    GEMORE OTC TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131281852·NERA2, MINIBTE 312 WL 85 STG

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100585·LIEBERMAN TEMPORAL SPECULUM K-WIRE

    Rumex

    FDA UDI
    RUMEX INTERNATIONAL CORP.·00840159903070·Chang Nucleus Hydrodissector, 27 Ga x 16.00 mm

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171027751·PESSARY, CUBE #10 W/DRAINS, 75mm

    ADVIA CHEMISTRY GLUH_3 REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 6, 2013

    THERMACHOICE III

    FDA Adverse Event
    Malfunction ·ETHICON·Product code MKN·June 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·February 25, 2022

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024