BEUDAMED
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    CONDUCTIVE EEG ELECTROLYTE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033052·Baltic Denture System BDLoad Mw7 PLSEbim6DFm D2...

    INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Cassette Test

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918000399·INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Ca...

    KONICA LASER IMAGER, DRYPRO MODEL 751/752

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUMED TYSHAK II AND Z-MED II PTV CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 1, 2013

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KOG·March 30, 2011

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·NORTH HAVEN - USS·Product code MFJ·April 22, 2008

    G7 FINNED 4 HOLE SHELL 54F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 8, 2023

    UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code HRY·July 18, 2006

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

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

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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024