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    EUROTROL GAS-ISE METABOLITES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664214685·ULTRA SHEER 30-40 MM HG KNEE HIGH CLOSED TOE EX...

    3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE

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

    THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE

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

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929065020·Corpectomy, 12Dx14Wx68H 0°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929040812·Corpectomy, 12Dx14Wx68H 6°

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2017

    EVOLUT PRO PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 3, 2024

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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 AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 22, 2019

    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 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 biplane, Model Number 10848282

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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024