BEUDAMED
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    CALF IMPLANT, MODEL EC17-X

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

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848489·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR30525051·Protrusion springs 0,50 mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450140512·

    Aero-Med

    FDA UDI
    AERO-MED, LLC·10810010892017·Adhesive Skin Sample Collection Kit

    SOPRO595 INTRA ORAL CAMERA

    FDA 510(k)
    FDA Class 1 ·Dental

    XIA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHLORAPREP ONE-STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXF·August 20, 2020

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 11, 2013

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 13, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·May 22, 2008

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A=32mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-140.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016