BEUDAMED
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    D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DP-REPAIR

    FDA UDI
    Denplus Inc·D8451061101·DP-REPAIR-R, SPL, 454 g

    Sycamore Wood Wedges

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783005035·WEDGE BOX OF 400 - 13T

    Micro Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70611011·Micro Sprint-Brackets Roth .018" 100 Brackets 3...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196877·Femoral Impactor Pad large

    XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4

    FDA 510(k)
    FDA Class 2 ·Neurology

    RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CYCLESURE BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·September 3, 2010

    GARBIN VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2013

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·April 18, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 13, 2008

    CYCLESURE BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·August 23, 2010

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012