BEUDAMED
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    CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSTACCULT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

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

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 14, 2025

    PNEUPAC TRANSPAC WITH INTEGRATED ALARM

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD·Product code BTL·April 22, 2013

    UNKNOWN ZIMMER MOST KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 3, 2011

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15MM ACTI

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·July 25, 2008

    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

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018