BEUDAMED
    16 results · 23ms · 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 ×

    GUIDANT BALLOON CATHETER, SEVERAL MODELS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854007228·ULTRAPOWER BUR, ACORN ( MUSTARD) 9 MM

    LIFEMATE HEMOFILTRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    2021283-1997-00040

    FDA Adverse Event
    Death ·IMED CORP·Product code FRN·August 4, 1997

    2021283-1996-00003

    FDA Adverse Event
    Malfunction ·Product code FRN·November 13, 1996

    ALARIS CAREFUSION SMARTSITE

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, ALARIS PRODUCTS·Product code FPA·March 20, 2013

    SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·March 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 25, 2008

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·February 27, 2024

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 22, 2018

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 22, 2018

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 22, 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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018