BEUDAMED
    21 results · 19ms · 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.

    BAHA INTENSO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000963·1.6mm x 6mm Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018760·1.6mm x 6mm Lag Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694029353·1.6mm x 6mm Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694025997·1.6mm x 6mm Center Drive Screw

    ALTIUS MINI IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code KWP·September 28, 2009

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694067164·HPS 1.6 x 6mm Lag Screw Sterile Qty 5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694054447·1.6mm x 6mm Screw Sterile Qty 10

    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PURESPERM BUFFER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·April 29, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 13, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·July 25, 2008

    1.6MM X 6MM SCREW

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code DZL·January 8, 2025

    1.6MM X 6MM SCREW

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code DZL·January 8, 2025

    1.6MM X 6MM SCREW

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code DZL·January 8, 2025

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·June 20, 2018

    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    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