BEUDAMED
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    TREP-SURE TREPONEMAL ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843996·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE FU...

    TI-DBLE LEAD CORT SCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018

    OSSEOTITE DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RELIANCE GENFORE WASHER

    FDA Adverse Event
    STERIS CANADA CORPORATION·Product code MEC·April 11, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    PALINDROME EMERALD 23/40KIT VT

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code MPB·May 28, 2008

    Thermalon Sinus Compress, Item Number 24332

    FDA Enforcement
    Class II ·Ongoing·Bruder Healthcare Company, LLC·April 3, 2024

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021

    TRI-LOCK BPS SZ 4 HI OFFSET

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015

    TRI-LOCK BPS SZ 7 STD OFFSET

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015

    i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.

    FDA Recall
    Terminated ·Imaging Sciences International, LLC·Product code JAK·October 30, 2009

    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

    FDA Recall
    Terminated ·Imaging Sciences International, LLC·Product code MUH·January 8, 2009

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021