BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ HT+ 98x30 C2

    FDA UDI
    ARGEN CORPORATION, THE·D818122121·Dental porcelain/ceramic restoration kit

    n/a

    FDA UDI
    Ortho Development Corporation·00822409077236·Collar Trial Assembly 21mm

    SEE H10

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·September 20, 2023

    SEE H10

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·September 20, 2023

    SEE H10

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·September 20, 2023

    PSG INPUT BOX, MODEL JE-912AK

    FDA 510(k)
    FDA Class 2 ·Neurology

    ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2023

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 17, 2013

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 18, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL LTD.·Product code KWA·June 3, 2011

    NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HAW·April 19, 2017

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura CV20, system code 722031

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015