BEUDAMED
    23 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 ×

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K121116

    FDA UDI
    Life Spine, Inc.·00190837016029·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016043·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016258·

    Standard CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034211·Ovoid Ø20mm, tube 1

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383500685·Gutta Percha Points is used to root canal filin...

    DONOR BOVINE SERUM, CAT. NO. 110-1116

    FDA 510(k)
    FDA Class 1 ·Hematology

    LASERTOUCHONE (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 30, 2002

    Widex

    FDA UDI
    Widex A/S·05706069885569·WIDEX MOMENT MRB0 (Dark cherry ) RIC 10

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    CURRENT PLUS VR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·May 9, 2013

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code BTI·September 19, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    THERMACARE LOWER BACK & HIP

    FDA Adverse Event
    Injury ·PFIZER CONSUMER HEALTH CARE·Product code IMD·December 21, 2017

    ACUMEN IQ CUFF ADULT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXN·July 3, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024