BEUDAMED
    16 results · 30ms · 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.

    VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS

    FDA 510(k)
    FDA Class 2 ·Hematology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694008433·2.4mm x 28mm Lag Screw

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111078699·INFANT DUAL STETH 30" BLACK

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035170·2.4 x 28mm Lag Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694067065·HPS 2.4 x 28mm Lag Screw Sterile Qty 5

    BHR MODULAR HEAD 46MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

    QUANTITATIVE BLOOD POOL SPECT (QBS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 12, 2011

    DEPUY VERSANAIL

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPEDICS, INC.·Product code HWC·June 6, 2008

    TAMPONADE URETERINE BALLOON CATHETER SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL·Product code KNA·October 16, 2007

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015