BEUDAMED
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    ELECSYS DHEA-S CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GoldSelect™

    FDA UDI
    ROCHESTER ELECTRO-MEDICAL, INC.·10816843020214·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...

    GoldSelect™

    FDA UDI
    Advantage Medical Electronics, LLC·00849593025140·Disposable GoldSelect™ Cup Electrodes: 9MM STAM...

    GoldSelect

    FDA UDI
    Advantage Medical Electronics, LLC·00849593009201·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...

    GoldSelect™

    FDA UDI
    ROCHESTER ELECTRO-MEDICAL, INC.·10816843020238·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...

    GoldSelect

    FDA UDI
    Advantage Medical Electronics, LLC·00849593009218·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...

    GoldSelect™

    FDA UDI
    Advantage Medical Electronics, LLC·00849593025188·Disposable GoldSelect™ Cup Electrodes: 9MM STAM...

    LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ASCENT XXL CLOSED BOX FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRULIANT TIB IMP CR INS STD SZ 4, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 5, 2022

    TRULIANT TIB IMP CR INS STD SZ 4, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 5, 2022

    POWER MODULE F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·March 14, 2013

    UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSA·February 24, 2011

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·February 22, 2008

    AS COLUMBUS REV F FEMUR ZEMENTIERT F5L

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·November 6, 2019

    13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·July 26, 2017

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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