BEUDAMED
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    VisualEyes

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108585·MICRO 500 MICRON NEEDLE, STAINLESS STEEL, UNINS...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540256805·HANDLE

    MIXTER FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896061071·MIXTER FORCEPS RIGHT ANGLED SERRATED TIP

    MEDTRONIC

    FDA Adverse Event
    Other ·MEDTRONIC, INC.·Product code LWS·April 1, 2005

    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDSTAR SYSTEM, MODELS 533-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013

    PROXIMAL HUMERUS, LEFT, ÿ 7X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·October 8, 2024

    LACTOSORB PLATES AND SCREWS

    FDA Adverse Event
    BIOMET MICROFIXATION·Product code HRS·April 30, 2010

    UNKNOWN KNEE FEMORAL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 7, 2019

    UNKNOWN KNEE TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 7, 2019

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code MAX·April 15, 2014

    UNKNOWN KNEE TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 7, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015