BEUDAMED
    12 results · 20ms · 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 ×

    GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DELFIA NEONATAL IRT KIT, MODEL A005-110

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COALESCENT SURGICAL U-CLIP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 12, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·June 20, 2008

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 20, 2011

    UNKNOWN PFM-R DISTAL STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·March 13, 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

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022