BEUDAMED
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    AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE

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

    JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MJS POSTERIOR STABILIZED KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·February 7, 2011

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·April 28, 2011

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·July 23, 2008

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NIO·April 1, 2025

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025