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.

    PAIN-AID

    FDA 510(k)
    FDA Class 2 ·Neurology

    8950 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020686·8950 PED LG MASK W/1420B 2W

    NA

    FDA UDI
    Nuvasive, Inc.·00195377165800·XLIF Cobb, 22mm VBR Tapered

    Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished)

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007

    Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·December 27, 2006

    SALUTE FIXATION DEVICE

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code GDW·March 17, 2005

    IND URINARY TRACT INFECTION (UTI) TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXCEL A.V FISUTAL NEEDLE SET

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

    PALAXPRESS, CLEAR, 1000G POWDER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    EON MINI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    REAMER

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTO·September 24, 2014

    VS3: NBP, SP02, TEMP

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MHX·May 25, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025