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

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    EXULT Knee Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOTA SLA Dental Implant System and LOTA HA Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Impertech Surgical Face Mask

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

    NA

    FDA UDI
    Zimmer, Inc.·00889024119536·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code LDF·September 9, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.

    FDA Recall
    Terminated ·NERL Diagnostics Corporation·Product code JWX·January 15, 2010

    Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.

    FDA Recall
    Terminated ·NERL Diagnostics Corporation·Product code JWX·January 15, 2010

    S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.

    FDA Recall
    Terminated ·Nerl Diagnostics LLC·Product code MRV·April 23, 2008