BEUDAMED
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    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed

    COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521106000·

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702597479·Elvarex 2/Knee High/Closed Toe/SoftFit

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1102000·Tray, 2 inch base

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1100000·Tray Lid, Universal Blank, Arcamed

    PROSTHODONTIC SCREWDRIVER , MODEL IA-400

    FDA 510(k)
    FDA Class 1 ·Dental

    SUPREMA POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·February 9, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2025

    TPRLC 133 MP TYPE1 BM SO 9.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 27, 2018

    LIGASURE ADVANCE

    FDA Adverse Event
    Malfunction ·COVIDIEN FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE·Product code GEI·May 6, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 8, 2025

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·August 4, 2022

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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