BEUDAMED
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    NICKERSON'S MED. SELECTIVE CULTURE MEDIU

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACUMED

    FDA UDI
    Acumed LLC·10806378044496·Hand & Wrist General Instrument Platter

    GRAFT DELIVERY SYSTEM MODEL SA-6115

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APC PLUS ADHESIVE

    FDA Adverse Event
    Injury ·3M UNITEK·Product code DYW·June 7, 2007

    UNKNOWN MAXIM BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 8, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSON·Product code LRK·October 17, 2012

    G2 X FILTER SYSTEM - JUGULAR

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 4, 2010

    PUREWICK FEMALE EXTERNAL CATHETER

    FDA Adverse Event
    Injury ·C.R. BARD INC. (COVINGTON) -1018233·Product code NZU·September 17, 2025

    UNKNOWN PUREWICK URINE COLLECTION SYSTEM

    FDA Adverse Event
    Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code NZU·October 17, 2025

    PUREWICK MALE EXTERNAL CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code NZU·February 19, 2026

    PUREWICK URINE COLLECTION SYSTEM

    FDA Adverse Event
    Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code NZU·January 9, 2026

    Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.

    FDA Recall
    Terminated ·Product code CBK·July 2, 2010

    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

    FDA Recall
    Terminated ·Product code CBK·August 8, 2014

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025