BEUDAMED
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    SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521111070·

    NA

    FDA UDI
    STERILMED, INC.·10888551030441·SAW BLADE SAGITTAL DUAL CUT SYSTEM 4, SYSTEM 20...

    NA

    FDA UDI
    STRYKER CORPORATION·04546540216809·Dual Cut Sagittal Blade

    MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO SOLO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 21, 2013

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 21, 2012

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 23, 2014

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code HWC·May 24, 2011

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 3, 2012

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·November 4, 2022

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 24, 2019

    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Artis Q.zen ceiling, Model Number 10848354

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

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    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

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018