BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    TPH Spectra+ Universal Composite Restorative

    FDA 510(k)
    FDA Class 2 ·Dental

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054118·PRLS 2NDMOL B/T 12DEG -27T 022 NDX LL

    FAC-4 - Miller & Long Concrete

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588121079·FAC-4 - Miller & Long Concrete

    KERRISON RONGUER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896093935·KERRISON RONGEUR UP-ANGLE TIP

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221046048·Unitek(TM) Molar Band General Purpose Narrow Re...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776116354·Keyhole Bracket

    SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSSTAPLE CHILL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 14, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 16, 2008

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Death ·SOPHYSA·Product code GWM·November 18, 2024

    C-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 24, 2020

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020