BEUDAMED
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    NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025

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

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    FDA Adverse Event
    Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

    Microgel®

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000037475·VENT TUBE 1082203 50PK PAPA TYPE 1.14

    Paparella

    FDA UDI
    MEDTRONIC XOMED, INC.·00613994146120·VENT TUBE 1082203 50PK PAPA TYPE 1.14

    Harvard PremiumFill A3

    FDA UDI
    Harvard Dental International GmbH·EHAR70822031·Universal light cure nano-hybrid composite for ...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR30822031·Sheet springs 0,15 x 20 x 3

    ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLAY-PARK LABS, INC. - LUBRICATING JELLY

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

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2013

    GIA* UNIVERSAL

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·July 25, 2008

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·May 9, 2011

    Polyflex Esophageal Stent 23/18mm x 120mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    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

    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