BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    MAC ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Varisoft™

    FDA UDI
    Unomedical A/S·05705244018693·Single use infusion set for subcutaneous infusi...

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103247·BRACKET LANG SINGLE WIDTH ANTERIOR 018 TQ=-3 A=...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450600726·

    TANDEM VARISOFT INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S / CONVATEC INC.·Product code FPA·July 1, 2019

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    VariSoft infusion set, Model Number 1002827

    FDA Recall
    Open, Classified ·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 13, 2013

    UNKNOWN DEPY PFC TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 16, 2011

    LAP CHOLE CDS - LF

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES·Product code GCJ·February 21, 2008

    VariSoft infusion set, Model Number 1002827

    FDA Enforcement
    Class I ·Ongoing·Unomedical A/S·November 29, 2023

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018