BEUDAMED
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    ALLERGEAZE R CLEAR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CapnoTrak

    FDA UDI
    Respironics Novametrix, LLC·00884838040014·CapnoTrak CO2 Nasal Cannula

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957004224·Genesis Urology Imaging System, Left, FPD, 80 K...

    Zethon

    FDA UDI
    ZETHON LIMITED·05060528013420·S-D09 - 90MM STRAIGHT ATTACHMENT (3.18MM)

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964100086·Endo Carry-On Procedure Kit

    PLATEAU-TL

    FDA UDI
    Life Spine, Inc.·00190837028770·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...

    ELECSYS FSH CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AT HOME DRUG TEST, MODEL 9074

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 17, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code HCG·May 17, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Artis Q floor, Model Number 10848280

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021