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    PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Nobel

    FDA UDI
    Preat Corporation·00842092167069·NobelBiocare™ Tri-Lobe-compatible RP Non-Engagi...

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741101182·Catheter Placement Kit

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005151·SC 25 lb Pwd Clear

    PedFlex Flexible Nailing System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132119594·ø1.5mm x 300mm Round Tip Flexible IM Nail

    PedFlex Flexible Nailing System

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132198261·Ø1.5 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL

    BARCOMED 2MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2025

    DREAMSTATION CPAP PRO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 8, 2025

    CAPSUREFIX

    FDA Adverse Event
    Death ·MPRI·Product code DTB·March 12, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code MIH·February 1, 2011

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 13, 2008

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 28, 2018

    LIFEGLOBAL MEDIA

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code MQL·July 10, 2025

    LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sensor REF 11996-000519 Masimo LNCS-II rainbow DCI 8 SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8 SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and methemoglobin saturation (SpMet) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·January 21, 2025

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·February 26, 2025