BEUDAMED
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    CONVOY ADVANCED DELIVERY SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    Safco T&F Bur - 12 Bladed

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310220673·Safco T&F bur - 12 bladed, carbide, #7408 egg F...

    CLINCARE LATEX SURGEON'S GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RADIANALYZER, MODEL 12710

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TECNIS CL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·March 26, 2013

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·March 10, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·March 28, 2008

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 14, 2022

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018