BEUDAMED
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    RESPIRONICS PR VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    1788 4K Camera System with Advanced Imaging Modality

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

    SATURNO(TM) OVERDENTURE IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEEP BRAIN STIMULATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·September 8, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2012

    KIRSCHNER WIRE, DIAM.1.0X160MM, (10/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·September 13, 2010

    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

    FDA Recall
    Terminated ·Vyaire Medical·Product code BTM·May 8, 2018

    AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

    FDA Recall
    Terminated ·Vyaire Medical·Product code BTM·May 8, 2018

    The Tri-Flo Subglottic Suction System

    FDA Recall
    Terminated ·Vyaire Medical·Product code BSY·June 20, 2018

    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

    FDA Recall
    Open, Classified ·Boston Scientific Neuromodulation Corporation·Product code LGW·July 17, 2024