BEUDAMED
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    LIVESURE METHAMPHETAMINE SCREEN TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517067432·Implant Inserter - 14x25 - XLIF

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040009468·Zirlux 16+ B4 coloring liquid

    OneCath

    FDA UDI
    COMPACTCATH, INC.·00852141007192·The OneCath Intermittent Urinary Catheter is a ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000147·1.6mm x 10mm Partially Threaded Auto-Drive Screw

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613072124·Tissue Forceps, 1 X 2 Teeth, Overall Length 24"...

    Gibson Healthcare

    FDA UDI
    BENCO DENTAL SUPPLY CO.·D74410116101·BENCO SILK BB 3-0 18" C31

    RETRACTOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWS·March 28, 2019

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043984·1.6mm x 10mm Partially Threaded Auto-Drive Screw

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

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

    M2A ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 25, 2019

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 13, 2023

    PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

    FDA 510(k)
    FDA Class 2 ·Immunology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 14, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·February 8, 2008

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code OVE·September 28, 2015

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022