BEUDAMED
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    THERMOFX MESH

    FDA 510(k)
    FDA Class 2 ·Dental

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092123393·Multi-Unit Titanium Screw (.048 Hex)

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092129043·Multi-Unit Titanium Screw (.048 Hex)

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092123409·Multi-Unit Titanium Screw (.048 Hex) (10-Pack)

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092129050·Multi-Unit Titanium Screw (.048 Hex) (10-Pack)

    AUTOSTAT II ENA-4 PROFILE ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ONCOLOGY SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·May 31, 2022

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·May 31, 2022

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    ALLOFT-S ALLOCLASSIC SHL 52/II

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code JDI·March 12, 2019

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·March 14, 2013

    INTERA 1.5T MASTER CV

    FDA Adverse Event
    Injury ·PHILIPS HEALTHCARE·Product code LNH·February 24, 2011

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·February 22, 2008

    ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·September 27, 2018

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    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