BEUDAMED
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    BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    t:flex Cartridge, t:lock, 10 Pack

    FDA UDI
    Tandem Diabetes Care, Inc.·00853052007493·t:flex Insulin Pump Cartridges, t:lock, 10 pack

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001390·artVeneer life lower anteriors, UBIL, C3

    Equinoxe

    FDA UDI
    Exactech, Inc.·10885862623881·Humeral Liner Trial, 36mm +2.5 Right

    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·September 26, 2025

    AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·September 26, 2025

    AVEIR¿ DELIVERY CATHETER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·October 1, 2025

    HIGH SPEED ROTARY ATTACHMENT

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 15, 2019

    2520274-2013-01426

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 13, 2013

    LAMITRODE 8 LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 17, 2011

    NONE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 23, 2008

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 25, 2024

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024