BEUDAMED
    17 results · 22ms · 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 ×

    MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CANCELLO-PURE WEDGE

    FDA Adverse Event
    Injury ·RTI BIOLOGICS·Product code MQV·June 13, 2012

    CANCELLO-PURE WEDGE

    FDA Adverse Event
    Injury ·RTI BIOLOGICS·Product code MQV·June 13, 2012

    CANCELLO-PURE WEDGE

    FDA Adverse Event
    Injury ·RTI BIOLOGICS·Product code MQV·June 13, 2012

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450225691·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450216125·

    GentleYAG LE

    FDA UDI
    Candela Corporation·00817495022659·Pulsed Laser

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258694702·

    BIOUNIVERSAL PDF

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BZE·May 21, 2010

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 3, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    SIMPLEX P - US HALF DOSE 10-PK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·May 12, 2011

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    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