BEUDAMED
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    MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180812200·

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057370397·SKYTRON 5.25" DELUXE GEL

    ENDOPATH SURESEAL REDUCER CAP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UNICIRCUIT

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE FINLAND OY·Product code BZO·September 19, 2008

    VNGD PS OPEN INTL FEM RT 70

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2019

    12/14 ARTICUL 40MM M SPEC+12

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. 8010379·Product code LPH·April 26, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS.·Product code LZG·July 23, 2008

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 12, 2024

    CANNULA & CATHETER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012