BEUDAMED
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    MODIFIED MERCI RETRIEVER, MODEL 90050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20620461·Arch wires Titanol Budget max. .018"x.025"

    MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 16, 2013

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 13, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015