BEUDAMED
    20 results · 21ms · 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 ×

    TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

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

    CO2 Sampling Nasal Cannula

    FDA UDI
    WESTMED, INC.·00709078004391·Adult Nasal Cannula, 10' O2/CO2 Sampling Line w...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776369514·Endoscopic video cart, 3 shelves, beige, soft r...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004770·5 Hole Straight Plate

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506086939·ENDOSCOPIC VIDEO CART, 3 SHELVES, BEIGE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694065122·1.6 System 5 Hole Straight Plate Sterile Qty 5

    EXPECT ENDOSCOPIC ASPIRATION NEEDLE

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

    TAPERLOC COMPLETE SIZE 4MM AND XR 123

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Free-Lock®

    FDA UDI
    Zimmer, Inc.·00889024035355·

    SOL-MILLENNIUM

    FDA Adverse Event
    Malfunction ·SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.·Product code FMF·May 16, 2025

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    MERSILENE POLYESTER FIBER MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·October 17, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 27, 2011

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 20, 2013

    45 degree Contra Angle Attachment Product Usage: Pneumatic system

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    90 degree Contra Angle Attachment Product Usage: Pneumatic system

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·March 14, 2013

    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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