BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072154·Endo Carry-On Procedure Kit

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111017087·TRAY PERF 20 3/4"X 12 3/4"X 4"

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111373491·TRAY PERF 20.75X12.75X4 PACK 6

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111256985·TRAY PERF 20 3/4X12 3/4X4 PK12

    ELK LASER IMAGER, MODEL EL-DRY 4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    WART FREEZE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MICRUSFRAME18 15MM X 50CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 1, 2020

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 6, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 18, 2011

    SAVVY PTA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS EUROPA, N.V.·Product code LIT·August 6, 2008

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021