BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    TITAN DENTAL IMPLANT ATTACHMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    HairCheck-DT (Opiates)

    FDA UDI
    Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809868043·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    ECAT PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 21, 2006

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 9, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 6, 2011

    VITALITY DS VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025