BEUDAMED
    27 results · 23ms · Sources: EU EUDAMED, US FDA

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    VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40

    FDA 510(k)
    FDA Class 2 ·Dental

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283723·MEYERDING FINGER RETRACTOR #6 7"

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809849134·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192237·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668116029·Tying Fcps Round Hdl, Straight, Titanium

    NIR BILIARY STENT

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

    ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SLEEPEASY

    FDA Adverse Event
    Injury ·RESPIRONICS INC.·Product code BZD·April 12, 2012

    REMSTAR PLUS M-SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code BZD·May 6, 2010

    REMSTAR M SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code BZD·November 25, 2009

    M-SERIES DC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 11, 2013

    ICAST

    FDA Adverse Event
    Malfunction ·ATRIUM MEDICAL CORPORATION·Product code JCT·March 18, 2011

    INAMED

    FDA Adverse Event
    Injury ·INAMED·Product code LTI·May 22, 2008

    REMSTAR PLUS M-SERIES

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code BZD·March 16, 2012

    Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Enforcement
    Class III ·Terminated·Viscot Medical LLC·April 10, 2013

    REMSTAR M SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·February 24, 2010

    REMSTAR PLUS M

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code BZD·May 21, 2010

    REMSTAR PLUS M-SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code BZD·December 1, 2010