BEUDAMED
    12 results · 21ms · 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 ×

    PYLO-PLUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809845518·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE-...

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 22, 2014

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 5, 2021

    KAVO CORUND HANDPIECE 2013

    FDA 510(k)
    FDA Class 2 ·Dental

    ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCREW

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL SPINE, INC.·Product code MRW·February 28, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP.·Product code CBK·May 23, 2008

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    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