BEUDAMED
    20 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MAHURKAR TRIPLE LUMEN CATHETER, 12 FR

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

    Megadyne

    FDA UDI
    MEGADYNE MEDICAL PRODUCTS, INC.·10614559103029·Center Heatsink Assembly, For Mega Power Generator

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450156278·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450156285·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197151672·Caspar Exploration- and Coagulation Hook, ...

    SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROSETTA-LT/ROSETTA-RX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    SYSTEM, PERITONEAL AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 25, 2013

    GPS PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·March 10, 2011

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FPA·March 18, 2026

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 27, 2015

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018

    DERMABOND ADVANCED 0.7ML - 12EA

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MPN·November 12, 2020

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015