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

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    Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526781726·LUMBAMED FACET 3 POINT SILVER V

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776303303·Smith-Petersen Osteotome, 8", curved, 1"

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931093·BIT, HEX FEMALE 1/2 1/4 SQ

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246782929·Trial

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122715·Modular Stem 21mm x 150mm

    NITRILE POWDERED EXAMINATION GLOVES (WHITE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADVIA Centaur CEA Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 15, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 26, 2013

    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·August 28, 2024

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013