BEUDAMED
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    CORAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRY PLUS EVO RX

    FDA UDI
    DENTAL MANUFACTURING SPA·08056865012476·ACRY PLUS EVO RX 6 UPPER

    Chemosite

    FDA UDI
    Covidien LP·10884521099203·Venous Access System

    Hose, Complete Set, Calf, Upper Thigh & Lower Thigh (AngioNew® V)

    FDA UDI
    VASOMEDICAL, INC.·00817980021280·Hose, Complete Set, Calf, Upper Thigh & Lower T...

    OptiMesh Multiplanar Expandable Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7403120047·Reverse Articulating Curette

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425579525·PT INSTRUMENT

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319703274·Tissue Forceps 7" (17.5cm), 1x2 teeth

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036031190·

    Malibu™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981029722·ROD CONNECTOR, 5.5/6.35

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197526609·Kelly Surgical Scissors curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197027908·Wagner Gum Scissors Fig. 1 curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197027915·Kelly Surgical Scissors curved...

    RUBICOR BREAST BIOPSY DEVICE

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

    SUREFIT DUAL DISPERSIVE ELECTRODE

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

    LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BC DISTRACT-BODY END ACTIV DISTRACTION-L

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MQN·May 20, 2013

    NEXGEN LCCK ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 7, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 15, 2008

    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·September 7, 2016

    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024