BEUDAMED
    89 results · 17ms · Sources: EU EUDAMED, US FDA

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    Orthex Large Bone Shoulder Bolt, model no. AS-17

    FDA Recall
    Open, Classified ·OrthoPediatrics Corp·Product code OSN·September 12, 2022

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Recall
    Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024

    INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007

    FDA Recall
    Open, Classified ·Mallinckrodt, LLC.·Product code MRN·June 23, 2022

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.

    FDA Recall
    Open, Classified ·Vyaire Medical·Product code BZE·April 10, 2025

    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.

    FDA Recall
    Open, Classified ·Vyaire Medical·Product code BZE·April 10, 2025

    Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Burdick. Product name: Cardiovive. Device Operation: Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

    FDA Recall
    Terminated ·Ino Therapeutics·Product code MRN·November 30, 2010

    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026

    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Recall
    Open, Classified ·ConMed Corporation·Product code HIF·May 14, 2026