BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PHILIPS M5066A AND M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JACKSON PRATT

    FDA Adverse Event
    Injury ·ALLEGIANCE HEALTHCARE CORP·Product code GCY·August 10, 1998

    BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·May 11, 2023

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 1, 2024

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 20, 2024

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·April 5, 2023

    BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·May 11, 2023

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025