BEUDAMED
    19 results · 24ms · 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 ×

    V-808 ATOM TRANSCAPSULE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0160710·Curette, Pull, #5

    PARADIGM QUICK-SET INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PCCS GRAFT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013

    ST JOSEPHS PHOENIX, AZ 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code DWF·July 31, 2009

    RU NOVOSIBRIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·October 16, 2013

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2013

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDS·April 1, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·June 13, 2008

    CP87641 GB SOUTHAMPTON

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·March 22, 2010

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    GII OVAL RESURFACING PAT 32MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

    D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017

    HI-TORQUE BALANCE MIDDLEWEIGHT

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·October 28, 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

    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