BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    EVERSTICK PERIO

    FDA 510(k)
    FDA Class 2 ·Dental

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644909·TRULOCK Light Activated Adhesive Mini Kit (1ea ...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030072·VENERE 30, SIZE L, GLACE, GRADUATED COMPRESSIO...

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037306123·HUMELOCK REVERSED RIGHT DELTO PECTORAL CUTTING ...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036023591·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306830327·Instrument Stringer, 40cm

    DORNIER MEDILAS D SKINPULSE

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

    PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    STERNAL ZIPFIX WITH NEEDLE STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDQ·April 2, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011

    IPUMP PAIN MANAGEMENT SYSTEMUS VERSION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 15, 2008

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·April 20, 2018

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·April 20, 2018

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021