BEUDAMED
    19 results · 38ms · Sources: EU EUDAMED, US FDA

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    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    Mini Spike Plus 6/8R

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JMS A.V.FISTULA NEEDLE SET

    FDA UDI
    JMS SINGAPORE PTE LTD·08888483005055·A.V.FISTULA 14GX1" BE 30CM W/CLAMP

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)

    MINOLTA PULSOX-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    R&D PROJECT DW269#25

    FDA 510(k)
    FDA Class 2 ·Dental

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 17, 2008

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 16, 2014

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 25, 2014

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 16, 2014

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 16, 2014

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·March 19, 2014

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·May 11, 2018

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·January 23, 2019

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020