BEUDAMED
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    TELEMED ERCP CANNULA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010775·Fixed, 4 electrode, MPA, 10mm electrode spacing

    POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENT PACK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code LRO·June 10, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 17, 2010

    Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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

    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