BEUDAMED
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    WRDensity by Whiterabbit.ai

    FDA 510(k)
    FDA Class 2 ·Radiology

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113456·HA PEEK EVOS Straight, ,13mmx8mmx 30mm , FLAT ...

    10PW - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose

    LUNGCARE CT SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNIPORT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELITE 202013 "H" STAPLE

    FDA Adverse Event
    Malfunction ·BIOMEDICAL ENTERPRISES, INC.·Product code JDR·February 1, 2016

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 10, 2022

    QUANTUM 2 SYSTEM

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·June 27, 2013

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    LAMITRODE S4

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 4, 2013

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·January 12, 2015

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·January 30, 2013

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·January 29, 2015

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    FDA Enforcement
    Class II ·Terminated·Hyperion Medical·August 27, 2014

    Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013