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

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    PENUMBRA DDC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ HT+ 95x22 A2

    FDA UDI
    ARGEN CORPORATION, THE·D818122772·Dental porcelain/ceramic restoration kit

    RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 21, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011

    UNK - CONSTRUCTS: VA-LCP

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·January 22, 2024

    UNK - CONSTRUCTS: 1/3 TUBULAR PLATE/SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·January 22, 2024

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

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

    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