BEUDAMED
    40 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bur PM2-70 50K Carb Ø2.3

    FDA UDI
    Bien-Air Surgery SA·07630055502421·

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780432531·Integra® Jarit® Metzenbaum Scissors, 8", Curved

    COOLEY TANGENTIAL OCCL CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921002660·COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW AN...

    COOLEY TANGENTIAL OCCL CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002104·COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW AN...

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 28, 2022

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2024

    COOK RETROGRADE INTUBATION SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code KRA·April 24, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 18, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 16, 2011

    UNK

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 10, 2018

    UNK

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 10, 2018

    Plastic Surgery Pack, part number AMS5685

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 9, 2023

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014