BEUDAMED
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    BIOLUCENT MAMMOGRAPHY CUSHION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Preat

    FDA UDI
    Preat Corporation·00842092186282·ASC NobelBiocare? Multi-Unit-compatible Non-Eng...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964024328·The ENDO CARRY-ON Procedure Kit contains all of...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073506·Carbide Bur RA 557

    THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 26, 2023

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

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

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS LLC (PR)·Product code NIQ·March 1, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 12, 2014

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2021

    ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.

    FDA Recall
    Terminated ·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024