BEUDAMED
    14 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 ×

    SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450586105·

    IMMIX BONE GRAFT EXTENDER

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

    MODIFICATION TO EBI SPINELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·April 30, 2013

    EP IMPLANT TRAY

    FDA Adverse Event
    Malfunction ·MEDICAL ACTION INDUSTRIES, INC.·Product code FSM·September 12, 2014

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 13, 2011

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012